Topcare Lice Killing

Manufacturer
Topco Associates, LLC | Weeks & Leo Co., Inc.
Effective date
2023-12-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:03:20

Label at a glance#

ProductTopcare Lice Killing
Active ingredientPYRETHRUM EXTRACT, PIPERONYL BUTOXIDE
Label structure11 sections

Indications and uses

treats head, pubic (crab), and body lice

Dosage and administration

Important: Read warnings before use Adults and children 2 years and over check each household member with a magnifying glass in bright light for lice/nits (eggs) 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 apply thoroughly t...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purposes

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.

if you have ever had an allergic reaction to this product or any of its ingredients

Ask 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 into eyes, flush with water right away
scalp itching or redness may occur

Stop and ask a doctor if

OTC - STOP USE SECTION

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

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Important: Read warnings before use
Adults and children 2 years and over

Inspect

DOSAGE & ADMINISTRATION SECTION

check each household member with a magnifying glass in bright light for lice/nits (eggs)
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

DOSAGE & ADMINISTRATION SECTION

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 their eggs (nits)

DOSAGE & ADMINISTRATION SECTION

se 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 the 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/nits. Repeat combing if necessary.
check daily for any lice/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: ask a doctor

Other Information

OTHER SAFETY INFORMATION

do not freeze
store at controlled room temperature 20°-25°C (68°-77°F)
see package insert for additional information

Inactive Ingredients

INACTIVE INGREDIENT SECTION

ammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol

Questions or comments?

OTC - QUESTIONS SECTION

to report serious side effects due to the use of this product call 1-877-974-7167

Additional Information

OTHER SAFETY INFORMATION

Hair Length - Recommended Application for 1 Adult/Child

Short (ear length or shorter) Day 1: 1-2 oz; Day 7-10: 1-2oz; Total : 2-4oz

Medium (shoulder length) Day1: 2-3oz; Day 7-10: 2-3oz; Total: 4-6oz

Long (past shoulder length) Day 1: 3-4oz; Day 7-10: 3-4oz; Total: 6-8oz

Important: keep this outer carton for future reference

Package Insert

INSTRUCTIONS FOR USE SECTION

Consumer Information

LICE KILLING SHAMPOO

For the treatment of Head Lice, Pubic (Crab) Lice and Body Lice

DIRECTIONS

Important: Read warnings before using this product. A second treatment must be done in 7-10 days to kill anu newly hatched lice eggs (nits)

Inspect

examine each household member with a magnifying glass in bright light for lice/eggs (nits)
look for tiny eggs (nits) near scalp, beginning at the back of neck and behind ears
examine small sections of hair
eggs (nits) stick to the hair
if either lice or eggs (nits) are found, treat with this product

Treat

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

To Remove Lice and Their Eggs (Nits)

use a special lice/nit or fine-toothed comb (included). Remove any remaining eggs (nits) by hand, using a throwaway glove
hair should remain slightly damp while removing eggs (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 the head. Longer hair may take 1 to 2 hours
lift a 1- to 2-inch wide strand of hair. Place comb firm, even motion away from scalp
pin back each strand of hair after combing
clean comb often. Wipe eggs (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/eggs (nits). Repeat combing if necessary
check daily for any lice/eggs (nits) that you missed
a second treatment must be done within 7 to 10 days to kill any newly hatched lice/eggs (nits)
if infestation continues, see a doctor for other treatments

1. HEAD LICE

head lice lay small white eggs (nits) on the hair shaft close to the scalp
eggs (nits) are most easily found on the back of the neck or behind the ears
disinfect hats, hair ribbons, scarves, coats, towels and bed linens by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 minutes
items that cannot be washed, dry cleaned or stored may be sprayed with a product designed for this purpose
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

2. PUBIC (CRAB) LICE

pubic (crab) lice may be contracted by sexual contact
sexual partners should be treated simultaneously to avoid reinfestation
lice are very small and look like brown or grey dots on the skin
pubic (crab) lice usually cause intense itching and lay small white eggs (nits) on the hair shaft generally close to the skin surface
pubic (crab) lice may be present on the short hairs of the groin, thighs, trunk, and underarms, -and occasionally on the beard, eyelids, and mustache
disinfect underwear by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 minutes

3. BODY LICE

body lice and their eggs (nits) are generally found in the seams of clothing, particularly in the waistline and armpit areas
body lice feed on skin then return to clothing to lay their eggs (nits)
disinfect clothing by machine washing in hot water [above 54 C (130 F)], then using the hottest dryer setting for at least 20 mintues
do not seal clothing in a plastic bag because eggs (nits) can remain dormant for up to 30 days

Save this insert for future reference

SHAKE WELL BEFORE USING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display PanelTopcare

Lice Killing Shampoo

Lice Treament Shampoo & Conditioner

A Liquid Lice Treatment for Human Use

For the Treatment of Head Lice and Body Lice

Compare to RID Lice Killing Shampoo active ingredients

8 fl oz (236 mL)

Includes One Lice Comb

NDC 76162-253-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooPSN1
283219piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated ShampooSCD1
283219piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated ShampooSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76162-253-08Topcare Lice Killing236 mL in 1 BOTTLESHAMPOO2361
76162-253-08Topcare Lice Killing1 in 1 CARTONSHAMPOO11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76162-253TOPCARE LICE KILLING (PIPERONYL BUTOXIDE, PYRETHRUM EXTRACT) SHAMPOO [TOPCO ASSOCIATES, LLC]1Current NDC, 2 package rows20231207_0be04816-e173-8046-e063-6294a90acdb6.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-25376162-253-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

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
Topcare Lice KillingPIPERONYL BUTOXIDE, PYRETHRUM EXTRACTTopco Associates, LLC0be04816-e173-8046-e063-6294a90acdb62023-12-06WarningsExact identifier
ndc (package): 76162-253-08
ndc (product): 76162-253
ndc11 (package): 76162025308
spl id: 0be04ad2-e1b6-d3fb-e063-6394a90ab8e5
spl set id: 0be04816-e173-8046-e063-6294a90acdb6

Reported adverse events (FAERS/openFDA)#

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