372819f1-0817-2cd5-e063-6294a90ac5bf
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
Piperonyl butoxide 4% Pyrethrum extract (equivalent to 0.33% pyrethrins)
Medication Information
Warnings and Precautions
For external use only
Indications and Usage
treats head, pubic (crab), and body lice
Dosage and Administration
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
Description
Piperonyl butoxide 4% Pyrethrum extract (equivalent to 0.33% pyrethrins)
Section 50565-1
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Section 50566-9
- breathing difficulty occurs
- eye irritation occurs
- skin or scalp irritation continues or infection occurs
Section 50567-7
- 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
Section 50569-3
- pregnant or breastfeeding
- allergic to ragweed. May cause breathing difficulty or an asthmatic attack.
Section 50570-1
- near eyes
- inside nose, mouth, or vagina
- on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.
Section 51727-6
ammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol
Section 51945-4
includes comb
Section 53413-1
Call 833-356-6431 Monday to Friday 9:00 am to 7:00 pm EST
Section 55105-1
Lice treatment
Section 55106-9
Piperonyl butoxide 4%
Pyrethrum extract (equivalent to 0.33% pyrethrins)
Section 59845-8
- 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
Section 60561-8
- 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
Structured Label Content
Indications and Usage (34067-9)
treats head, pubic (crab), and body lice
Dosage and Administration (34068-7)
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
Warnings and Precautions (34071-1)
For external use only
Section 50565-1 (50565-1)
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Section 50566-9 (50566-9)
- breathing difficulty occurs
- eye irritation occurs
- skin or scalp irritation continues or infection occurs
Section 50567-7 (50567-7)
- 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
Section 50569-3 (50569-3)
- pregnant or breastfeeding
- allergic to ragweed. May cause breathing difficulty or an asthmatic attack.
Section 50570-1 (50570-1)
- near eyes
- inside nose, mouth, or vagina
- on lice in eyebrows or eyelashes. See a doctor if lice are present in these areas.
Section 51727-6 (51727-6)
ammonium laureth sulfate, fragrance, PEG-25 hydrogenated castor oil, polyquaternium-10, purified water, SD-40 alcohol
Section 51945-4 (51945-4)
includes comb
Section 53413-1 (53413-1)
Call 833-356-6431 Monday to Friday 9:00 am to 7:00 pm EST
Section 55105-1 (55105-1)
Lice treatment
Section 55106-9 (55106-9)
Piperonyl butoxide 4%
Pyrethrum extract (equivalent to 0.33% pyrethrins)
Section 59845-8 (59845-8)
- 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
Section 60561-8 (60561-8)
- 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
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Raw Label Data
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Source: dailymed · Ingested: 2026-02-15T12:06:50.486139 · Updated: 2026-03-14T23:09:50.407692