Lice Killing Shampoo Drug Facts

Set ID
0bc2cddc-2873-09cc-e054-00144ff88e88
Manufacturer
Select Brand | Weeks & Leo Co., Inc.
Effective date
2015-01-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:41:21

Key Label Information

Active Ingredients And Purpose

Active ingredient

Piperonyl butoxide 4% Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purpose

Lice treatment

Uses

Uses

treats head, pubic (crab), and body lice

Warnings

Warnings

For external use only

Directions And Dosage

Directions

Important: Read warnings before use Adults and children 2 years and over: Inspect 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 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) 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 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 Label Information

Other information

do not freeze store at controlled room temperature 20°-25°C (68°-77°F) to report serious side effects due to the use of this product call (515) 276-1586 see package insert for additional information

Inactive ingredients

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

Principal Display Panel

select brand Maximum Strength LICE KILLING SHAMPOO LICE TREATMENT SHAMPOO & CONDITIONER IN ONE Instructiones En Español Includas •Works fast to kill lice and eggs •Helps children return to school "lice free" Compare to the Active Ingredients in RID® one comb included

Products

NDC Codes

Ingredients

NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
POLYQUATERNIUM-10 (400 MPA.S AT 2%)HB1401PQFSIACT
PEG-25 HYDROGENATED CASTOR OIL0ZNO9PJJ9JIACT
AMMONIUM LAURETH-2 SULFATE698O4Z48G6IACT
PIPERONYL BUTOXIDELWK91TU9AHACTIB
PYRETHRUM EXTRACTZUM06L90GVACTIB

Complete SPL Sections

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Piperonyl butoxide 4% Pyrethrum extract (equivalent to 0.33% pyrethrins)

Uses

INDICATIONS & USAGE SECTION

treats head, pubic (crab), and body lice

Purpose

OTC - PURPOSE SECTION

Lice treatment

Warnings

WARNINGS SECTION

For external use only

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

do not freeze store at controlled room temperature 20°-25°C (68°-77°F) to report serious side effects due to the use of this product call (515) 276-1586 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

Additional Information

SPL UNCLASSIFIED SECTION

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 Largo del cabello - Cantidad recomendada para 1 adulto/niño Corto (hasta la oreja o más corto) Dia 1: 1-2oz; Dia7-10: 1-2oz; Total: 2-4oz Medio (hasta el hombro) Dia1: 2-3oz; Dia 7-10: 2-3oz; Total: 4-6oz Largo (más abajo del hombro) Dia 1: 3-4oz; Dia 7-10: 3-4oz; Total: 6-8oz Important: keep this outer carton for future reference.

Package Insert

SPL PATIENT PACKAGE INSERT SECTION

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

select brand Maximum Strength LICE KILLING SHAMPOO LICE TREATMENT SHAMPOO & CONDITIONER IN ONE Instructiones En Español Includas •Works fast to kill lice and eggs •Helps children return to school "lice free" Compare to the Active Ingredients in RID® one comb included

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

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XML SHA-256
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Legacy File Index

FolderFileDate
otc0bc2cddc-2876-09cc-e054-00144ff88e88.xml2015-01-13
otcLKS_Insert.jpg2015-01-13
otcSB_LKS_2oz_box.jpg2015-01-13