Permethrin Lotion 1%

Manufacturer
Rebel Distributors Corp
Effective date
2011-12-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:31:22

Label at a glance#

ProductLice Treatment
Active ingredientPERMETHRIN
Label structure15 sections

Dosage and administration

all household members should be checked by another person for lice and/or nits (eggs) use a magnifying glass in bright light to help you see the lice and nits (eggs) use a tool, such as a comb or two unsharpened pencils to lift and part the hair look for tiny nits near the scalp, beginning at the back of the neck and behind the ears small sections of hair (1-2 inches wide) should be examined at a time unlike dandr...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each fluid ounce)

Permethrin 280 mg (1%)

PURPOSE

OTC - PURPOSE SECTION

Lice treatment

USE

INDICATIONS & USAGE SECTION

Treats head lice

WARNINGS

WARNINGS SECTION

For external use only

DO NOT USE

OTC - DO NOT USE SECTION

on children under 2 months of age

SPL UNCLASSIFIED SECTION

  • near the eyes
  • inside the nose, ear, mouth, or vagina
  • on lice in eyebrows or eyelashes. See your doctor.

ASK A DOCTOR BEFORE USE IF YOU ARE

OTC - ASK DOCTOR SECTION

  • allergic to ragweed. May cause breathing difficulty or an asthmatic episode.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

  • keep eyes tightly closed and protect eyes with a washcloth or towel
  • if product gets into the eyes, immediately flush with large amounts of water
  • scalp itching or redness may occur

STOP USE AND SEE A DOCTOR IF

OTC - STOP USE SECTION

side effects occur.

SPL UNCLASSIFIED SECTION

breathing difficulty occurs

SPL UNCLASSIFIED SECTION

eye irritation occurs

SPL UNCLASSIFIED SECTION

  • skin or scalp irritation continues or infection occurs

PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Inspect

SPL UNCLASSIFIED SECTION

  • all household members should be checked by another person for lice and/or nits (eggs)
  • use a magnifying glass in bright light to help you see the lice and nits (eggs)
  • use a tool, such as a comb or two unsharpened pencils to lift and part the hair
  • look for tiny nits near the scalp, beginning at the back of the neck and behind the ears
  • small sections of hair (1-2 inches wide) should be examined at a time
  • unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.
  • if either lice or nits (eggs) are found, treat with Permethrin Lotion 1%
Treat

SPL UNCLASSIFIED SECTION

  • wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of Permethrin Lotion 1%. Rinse with water.
  • towel dry hair so it is damp but not wet
  • shake the bottle of Permethrin Lotion 1% well
  • completely saturate the hair and scalp with Permethrin Lotion 1%. Begin to apply Permethrin Lotion 1% behind the ears and at the back of the neck.
  • keep Permethrin Lotion 1% out of the eyes. Protect the eyes with a washcloth or towel.
  • leave Permethrin Lotion 1% on the hair for 10 minutes, but no longer
  • rinse with warm water
  • towel dry hair and comb out tangles
  • if live lice are seen seven days or more after the first treatment, a second treatment should be given
Remove Lice/Nits

SPL UNCLASSIFIED SECTION

  • remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out.
  • use the nit comb provided and make sure the hair remains slightly damp while removing nits
  • if the hair dries during combing, dampen it slightly with water
  • part the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2 hours).
  • start at the top of the head on the section you have picked
  • with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair.
  • use clips to pin back each strand of hair after you have combed out the nits
  • clean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back.
  • after combing, recheck the entire head for nits and repeat combing if necessary
  • check the affected head daily to remove any nits that you might have missed

    Other information

  • read all the directions in the Consumer Information Insert and warnings before use. Keep the carton. It contains important information.
  • store at 20° to 25°C (68° to 77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Balsam fir canada, cetyl alcohol, citric acid, FD&C yellow #6, fragrance, hydrolyzed

animal protein, hydroxyethylcellulose, isopropyl alcohol, methylparaben, polyoxyethylene

10 cetyl ether, propylene glycol, propylparaben, purified water, stearalkonium chloride

QUESTIONS?

OTC - QUESTIONS SECTION

1-800-432-8534 (select option # 2) between 9 am and 4 pm EST, Monday – Friday.

Patient Information

INSTRUCTIONS FOR USE SECTION

Single Application

Lice Treatment

Permethrin Lotion 1%

With A Single Application:

  • Kills Lice & Their Eggs
  • Prevents Reinfestation for 14 Days

    Creme Rinse With Nit Removal Comb

    2 FL OZ (59 mL)

Information for Patients

SPL UNCLASSIFIED SECTION

Consumer Information Insert

Permethrin Lotion 1%

Lice Treatment

Please read all information before using Permethrin Lotion 1%.

If you or a member of your household has lice, don’t panic. Keep calm.

Anyone can get head lice – it has nothing to do with cleanliness or poor hygiene. Head lice are treatable and very rarely cause serious health problems.

What are head lice?

  • head lice are small insects that live and feed on the human scalp
  • they may get as big as sesame seeds and are brown
  • lice do not fly or jump from one person to another. They can only crawl.

    What are nits?

  • nits are lice eggs laid on the hair near the scalp. One louse may lay over 100 nits.
  • nits are oval shaped, tiny and greyish-white
  • they are attached to hair with a waterproof glue-like substance that cannot be washed out or blown away

    Because nits (eggs) hatch in about one week, all nits must be removed to stop lice.

    How do head lice spread?

  • head lice spread easily from close head-to-head or hand-to-head contact with persons who have lice
  • they may also spread by sharing hats, helmets, scarves, headphones, brushes, combs, bedding and clothing

    How do you know if you have lice?

  • itching is the most common symptom
  • scratching behind the ears or the back of the neck is a sign that you should check for head lice
  • scabs or blood spots may be seen

    How do you prevent the spread of lice?

  • do not share or borrow personal items like combs, brushes, or headbands
  • do not share or borrow hats, sweaters, coats, scarves, helmets, headphones, pillows or stuffed animals
  • store hats in coat sleeves and hang coats separately, so that they do not touch other people’s hats and coats
  • wash under fingernails when you first see lice or nits (eggs)
  • check your child’s head daily when you hear of a lice outbreak in day care or school

    How to use Permethrin Lotion 1%

    1. Inspect

      If you suspect head lice – check. Head lice may be hard to locate because they avoid light. Nits are easier to see.

  • all household members should be checked by another person for lice and/or nits (eggs)
  • use a magnifying glass in bright light to help you see the lice and nits (eggs)
  • use a tool, such as a comb or two unsharpened pencils to lift and part the hair
  • look for tiny nits near the scalp, beginning at the back of the neck and behind the ears
  • small sections of hair (1-2 inches wide) should be examined at a time
  • unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.T:\Maryland\NJ\Juan\ANDA 075014\mother-n-child.jpgT:\Maryland\NJ\Juan\ANDA 075014\mother-n-child.jpg
  • PICTURE OF MOTHER CHECKING FOR LICEPICTURE OF MOTHER CHECKING FOR LICE
  • if either lice or nits (eggs) are found, treat with Permethrin Lotion 1%
    1. Treat
  • wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner or a conditioner alone since this may decrease the activity of Permethrin Lotion 1%. Rinse with water.
  • towel dry hair so it is damp but not wet
  • shake the bottle of Permethrin Lotion 1% well
  • completely saturate the hair and scalp with Permethrin Lotion 1%. Begin to apply Permethrin Lotion 1% behind the ears and at the back of the neck.
  • keep Permethrin Lotion 1% out of the eyes. Protect the eyes with a washcloth or towel.
  • leave Permethrin Lotion 1% on the hair for 10 minutes, but no longer
  • rinse with warm water
  • towel dry hair and comb out tangles
  • if live lice are seen seven days or more after the first treatment, a second treatment should be given
  • PICTURE OF CHILD WITH SHAMPOO ON HAIRPICTURE OF CHILD WITH SHAMPOO ON HAIR
    1. Remove Lice/Nits

      Treatment kills lice but does not remove the nits.

  • remove nits by combing the hair with the special small tooth comb provided. Remaining nits may be removed by hand (using a throw-away glove), or cutting the nits out.
  • use the nit comb provided and make sure the hair remains slightly damp while removing nits
  • if the hair dries during combing, dampen it slightly with water
  • part the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2 hours).
  • start at the top of the head on the section you have picked
  • with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as possible and comb with a firm, even motion away from the scalp to the end of the hair.
  • use clips to pin back each strand of hair after you have combed out the nits
  • clean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away the tissue in a sealed plastic bag to prevent the lice from coming back.
  • after combing, recheck the entire head for nits and repeat combing if necessary
  • check the affected head daily to remove any nits that you might have missed
  • PICTURE SHOWING HOW TO COMB HAIRPICTURE SHOWING HOW TO COMB HAIR
    1. Clean home and personal items

      After using Permethrin Lotion 1%, it is very important to clean personal items and your home to prevent the spread of lice. Nits may live away from the human head for about 7-12 days. Lice may live away from the human head for about 1 day.

  • all personal head gear (hats, hair ribbons, etc.), scarves, coats, towels and bed linens should be washed in hot water (above 130°F), then dried in the dryer using the hottest cycle for at least 20 minutes
  • personal combs, including nit combs, and brushes should be soaked in hot water (above 130°F) for at least 10 minutes
  • personal articles such as clothing, bedspreads, blankets, pillows or stuffed animals that cannot be washed should be dry-cleaned or sealed tightly in a plastic bag for a period of at least 4 weeks. Items should be taken out of the plastic bag outdoors and shaken out very hard before using again.
  • for anything you cannot wash, dry-clean or store in a plastic bag, spray with a product that kills lice
  • vacuum everywhere. Vacuum all carpets, mattresses, upholstered furniture and car seats that may have been used by infested household members.
  • PICTURE OF MOTHER CLEANINGPICTURE OF MOTHER CLEANING

    WARNINGS

    For external use only

    Do not use

on children under 2 months of age

SPL UNCLASSIFIED SECTION

  • near the eyes
  • inside the nose, ear, mouth, or vagina
  • on lice in eyebrows or eyelashes. See your doctor.

    Ask a doctor before use if you are

  • allergic to ragweed. May cause breathing difficulty or an asthmatic episode.

When using this product

  • keep eyes tightly closed and protect eyes with a washcloth or towel
  • if product gets into the eyes, immediately flush with large amounts of water
  • scalp itching or redness may occur

Stop use and see a doctor if

  • breathing difficulty occurs
  • eye irritation occurs
  • skin or scalp irritation continues or infection occurs

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Questions? 1-800-432-8534 (select option # 2).

Form No. 5242-PI

Rev. 8/08

VC 3202

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Lice Treatment (Permethrin Lotion) 1%Lice Treatment (Permethrin Lotion) 1%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
250387permethrin 1 % Medicated ShampooPSN1
250387permethrin 10 MG/ML Medicated ShampooSCD1
250387permethrin 1 % Medicated ShampooSY1
250387permethrin 1 % Topical LotionSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PERMETHRIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f33e3e13-1328-47a9-3012-134a14fcb6a1Product name220190703

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-065-602019-09-24C16284748780-19350213a-3c0e-c013-e053-90daa90a1393Permethrin Lotion 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-065-60Lice Treatment59 mL in 1 BOTTLELOTION591
42254-065-60Lice Treatment1 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-065LICE TREATMENT (PERMETHRIN) LOTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20120411_6efbbff4-db09-4d9d-93dd-6b6ce9271514.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-065-60ML - Milliliter42254-065f5364ac9-206e-473e-bad0-1d6c46d359ce12012-07-24
0472-5242-67ML - Milliliter0472-5242a043cbdc-071a-4df1-81c1-780583ca588f12012-07-24
0472-5242-69ML - Milliliter0472-5242c39682a1-5222-4935-9a67-3f0f2f0e8af712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PERMETHRINACTIVE INGREDIENT509F88P9SZ1
PERMETHRINACTIVE MOIETY509F88P9SZ1
CANADA BALSAMINACTIVE INGREDIENTK304VI98I31
CETETH-10INACTIVE INGREDIENTLF9X1PN3XJ1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163021
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
STEARALKONIUM CHLORIDEINACTIVE INGREDIENT0OUO26BB881
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42254-06542254-065-60
0472-5242

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 7 · 382 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAMUSCULAR28 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
34 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY / NASAL9 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL / TOPICAL1.16 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, ORALLY DISINTEGRATING / ORAL9 mgExact identifier — unii candidate
20 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION / ORAL269 mgExact identifier — unii candidate
88 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SPONGE / TOPICAL0.01 %w/wExact identifier — unii candidate
34 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8LIQUID / ORAL0.2 mg/1mlExact identifier — unii candidate
34 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPELIXIR / ORAL100 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCONCENTRATE / ORAL12 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, DELAYED RELEASE / ORAL36 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / SUBLINGUAL1 mgExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAVENOUS396 mgExact identifier — unii candidate
88 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION, CONCENTRATE / IRRIGATION1 mgExact identifier — unii candidate
88 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii candidate
34 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / TOPICAL0.01 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS385 mgExact identifier — unii candidate
88 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRALESIONAL0.15 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET, CHEWABLE / ORAL0.41 mgExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / TOPICAL1800 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302TABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
9 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / ORAL446 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8SUSPENSION / ORAL11 mgExact identifier — unii candidate
34 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
CETETH-10CETETH-10LF9X1PN3XJLOTION / TOPICAL2.5 %w/wExact identifier — unii candidate
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRA-ARTICULAR0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
79 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER / ORAL840 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRA-ARTICULARADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / PARENTERAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYRUP / ORAL722 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075014-001PERMETHRINPERMETHRIN1%LOTION / TOPICAL2000-03-28

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-2884e616aacf4f…
2026-08-18 06:07:402026-07A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-283f01610625f2…
2019-09-15 20:21 UTC2019-09A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A075014-001PERMETHRIN1%LOTION / TOPICAL2000-03-28f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
6efbbff4-db09-4d9d-93dd-6b6ce92715146efbbff4-db09-4d9d-93dd-6b6ce92715142011-12-20WarningsExact identifier
spl id: 6efbbff4-db09-4d9d-93dd-6b6ce9271514
spl set id: 6efbbff4-db09-4d9d-93dd-6b6ce9271514

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.