SPL v1
SPL
SPL Set ID 372819f1-0817-2cd5-e063-6294a90ac5bf
Route
TOPICAL
Published
Effective Date 2025-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Piperonyl Butoxide (4 g) Pyrethrum Extract (0.33 g)
Inactive Ingredients
Ammonium Laureth-3 Sulfate Water Polyquaternium-10 (400 Cps At 2%) Peg-25 Hydrogenated Castor Oil Alcohol

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-01

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


Advanced Ingredient Data


Raw Label Data

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