Pronto Plus

Manufacturer
Insight Pharmaceuticals LLC
Effective date
2011-01-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:19

Label at a glance#

ProductPronto Plus Lice Killing
Active ingredientPyrethrum Extract, Piperonyl Butoxide
Label structure13 sections

Indications and uses

treats head, pubic (crab) and body lice

Dosage and administration

Important: Read warnings before use. Adults and children 2 years of age and over: Inspect check each household member with a magnifying glass in bright light for lice and nits look for tiny nits near scalp, beginning at back of neck and behind ears examine small sections of hair at a time unlike dandruff which moves when touched, nits stick to the hair if either lice or nits are found, treat with this product   Tr...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Lice Killing Shampoo with Extracts

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Pyrethrum extract (pyrethrins 0.33%) with piperonyl butoxide 4%

Purpose

OTC - PURPOSE SECTION

Lice treatment

Uses

INDICATIONS & USAGE SECTION

treats head, pubic (crab) and body lice

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • near eyes
  • inside nose, mouth or vagina
  • on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.

Ask a doctor before use if you are

OTC - ASK DOCTOR SECTION

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

When using this product

OTC - WHEN USING SECTION

  • keep eyes tightly closed and protect eyes with a washcloth or towel
  • if product gets in eyes, flush with water right away
  • scalp itching or redness may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

Directions

DOSAGE & ADMINISTRATION SECTION

Important: Read warnings before use.

  • Adults and children 2 years of age and over:
    Inspect
    • check each household member with a magnifying glass in bright light for lice and nits
    • look for tiny nits near scalp, beginning at back of neck and behind ears
    • examine small sections of hair at a time
    • unlike dandruff which moves when touched, nits stick to the hair
    • if either lice or nits are found, treat with this product
       
    Treat
    • shake bottle well
    • apply thoroughly to dry hair or other affected area. For head lice, first apply behind ears and to back of neck.
    • allow product to remain for 10 minutes, but no longer
    • use warm water to form a lather, shampoo, then thoroughly rinse
    • for head lice, towel dry hair and comb out tangles
       
    Remove lice and nits
    • use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove).
    • hair should remain slightly damp while removing nits
    • if hair dries during combing, dampen slightly with water
    • for head lice, part hair into sections. Do one section at a time starting on top of head. Longer hair may take 1 to 2 hours.
    • lift a 1- to 2- inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp.
    • pin back each strand of hair after combing
    • clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back.
    • after combing, thoroughly recheck for lice and nits. Repeat combing if necessary.
    • check daily for any lice and nits that you missed
    • a second treatment must be done in 7 to 10 days to kill any newly hatched lice
    • if infestation continues, see a doctor for other treatments
  • Children under 2 years of age: ask a doctor

Other Information

SPL UNCLASSIFIED SECTION

HEAD LICE: lay small white eggs (nits) on hair shaft close to scalp

  • nits are most easily found on back of neck or behind ears
  • disinfect hats, hair ribbons, scarves, coats, towels, and bed linens by machine washing in hot water [above 54°C (130°F)], then using hottest dryer cycle for at least 20 minutes
  • items that cannot be washed (bedspreads, blankets, pillows, stuffed toys, etc.) should be dry-cleaned or sealed in a plastic bag for 4 weeks, then removed outdoors and shaken out very hard before using again
  • items that cannot be washed, dry-cleaned, or stored may be sprayed with a product designed for this purpose
  • allow all sprayed articles to dry thoroughly before use
  • soak all combs and brushes in hot water [above 54°C (130°F)] for at least 10 minutes
  • vacuum all carpets, mattresses, upholstered furniture, and car seats that may have been used by affected people

Keep carton for full drug facts and warnings. Read all warnings and directions before use.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

cananga odorata flower oil, chamomilla recutita (matricaria) flower extract, fragrance, melaleuca alternifolia (tea tree) leaf oil, PEG-45 palm kernel glycerides, pimpinella anisum (anise) fruit extract, propylene glycol, water, sodium laureth sulfate.

Questions?

OTC - QUESTIONS SECTION

call 1-888-542-3546

SPL UNCLASSIFIED SECTION

Distributed by:
INSIGHT Pharmaceuticals Corp.
1170 Wheeler Way
Langhorne, PA 19047-1749

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRONTO®
PLUS

Complete Lice Removal System

3-STEP LICE ELIMINATION KIT

  • LICE KILLING SHAMPOO WITH EXTRACTS
    Pyrethrum extract (pyrethrins 0.33%) with piperonyl butoxide 4% (Lice treatment)
  • MAXIMUM STRENGTH LICE KILLING INGREDIENT TO KILL LICE & NITS (their eggs)
  • CONTAINS CHAMOMILE, ANISE, YLANG YLANG OIL & TEA TREE OIL
  • LEAVES NO CHEMICAL RESIDUE BEHIND
  • LICE EGG REMOVER GEL AND COMB
  • GEL MAKES LICE NIT (EGG) REMOVAL EASIER THAN
    LICE KILLING SHAMPOO ALONE
  • INCLUDES NIT REMOVAL COMB
  • PRONTO® PLUS HOUSEHOLD SPRAY KILLS
    LICE, TICKS, FLEAS, DUST MITES & BEDBUGS
  • Kills Adult Lice & Nymphs as They Hatch on Bedding, Garments, Furniture and Other Inanimate Objects

CAUTION: KEEP OUT OF REACH OF CHILDREN
See Back/Side Panel For Additional Precautions And First Aid

SHAMPOO 2 FL OZ (59 mL), GEL 2 FL OZ (59 mL), COMB, GLOVES, SPRAY 5 OZ (142 g)

Principal Display Panel - Kit Carton
Principal Display Panel - Kit Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooPSN1
729773Pronto Plus 4 % / 0.33 % Medicated ShampooPSN1
729773piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated Shampoo [Pronto Plus]SBD1
283219piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated ShampooSCD1
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooSY1
729773Pronto Maximum Strength (piperonyl butoxide 4 % / pyrethrins 0.33 % ) Medicated ShampooSY1
729773Pronto Plus (piperonyl butoxide 4 % / pyrethrins 0.33 % ) Medicated ShampooSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63736-210-122019-10-29C16284748780-1960f7f55-caf4-8e05-e053-dbdaa90a074aPRONTO ® PLUS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-210-12Pronto Plus Lice Killing1 in 1 BOXSHAMPOO11
63736-210-12Pronto Plus Lice Killing12 in 1 CASESHAMPOO121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-210PRONTO PLUS (PYRETHRUM EXTRACT AND PIPERONYL BUTOXIDE) SHAMPOO [INSIGHT PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20110228_3cdec6f3-4da6-467f-96c3-c8941ff46b56.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Piperonyl ButoxideACTIVE INGREDIENTLWK91TU9AH1
Pyrethrum ExtractACTIVE INGREDIENTZUM06L90GV1
Piperonyl ButoxideACTIVE MOIETYLWK91TU9AH1
Pyrethrum ExtractACTIVE MOIETYZUM06L90GV1
Cananga OilINACTIVE INGREDIENT8YOY78GNNX1
ChamomileINACTIVE INGREDIENTFGL3685T2X1
Pimpinella AnisumINACTIVE INGREDIENTHO63CL229O1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V31
Sodium Laureth SulfateINACTIVE INGREDIENTBPV390UAP01
Tea Tree OilINACTIVE INGREDIENTVIF565UC2G1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63736-21063736-210-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 2 · 86 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium Laureth SulfateSODIUM LAURETH-3 SULFATEBPV390UAP0TABLET / ORAL0.91 mgExact identifier — unii candidate
5 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / OPHTHALMIC1 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SYRUP / ORAL5700 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium Laureth SulfateSODIUM LAURETH-3 SULFATEBPV390UAP0SHAMPOO / TOPICAL3192 mgExact identifier — unii candidate
5 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / OPHTHALMIC0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3OINTMENT, AUGMENTED / TOPICAL714 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM / VAGINAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / DENTAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3DROPS / ORAL200 mg/1mlExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / RESPIRATORY (INHALATION)10 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LIQUID / ORAL29008 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
Sodium Laureth SulfateSODIUM LAURETH-3 SULFATEBPV390UAP0CREAM / TOPICALNAExact identifier — unii candidate
5 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3ELIXIR / ORAL9306 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAVENOUS4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL, METERED / TOPICAL1225 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / VAGINAL6.4 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / TRANSDERMAL500 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SPRAY / NASAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM / TOPICAL76000 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3SOLUTION / INTRAVENOUS5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
Propylene GlycolPROPYLENE GLYCOL6DC9Q167V3CREAM, AUGMENTED / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates

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
2d148ca6-9415-44c3-a791-d5d3ce13ea7c3cdec6f3-4da6-467f-96c3-c8941ff46b562011-01-20WarningsExact identifier
spl id: 2d148ca6-9415-44c3-a791-d5d3ce13ea7c
spl set id: 3cdec6f3-4da6-467f-96c3-c8941ff46b56

Reported adverse events (FAERS/openFDA)#

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