Topcare Lice Killing Shampoo

Topcare Lice Killing Shampoo
SPL v1
SPL
SPL Set ID 0be04816-e173-8046-e063-6294a90acdb6
Route
TOPICAL
Published
Effective Date 2023-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: yellow
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-11-01

Description

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

Purpose

Lice Treatment


Medication Information

Purpose

Lice Treatment

Description

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

Uses

treats head, pubic (crab), and body lice

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

Section 51945-4

Topcare

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

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

Purposes

Lice Treatment

Warnings

For external use only

Directions

Important: Read warnings before use

Adults and children 2 years and over

Do Not Use

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

Package Insert

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

Active Ingredient

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Other Information

do not freeze

store at controlled room temperature 20°-25°C (68°-77°F)

see package insert for additional information

Inactive Ingredients

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

Additional 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

Questions Or Comments?

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

When Using This Product

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

breathing difficulty occurs

eye irritation occurs

skin or scalp irritation continues or infection occurs

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask Doctor Before Use If You Are

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

Remove Lice and Their Eggs (nits)

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


Structured Label Content

Uses

treats head, pubic (crab), and body lice

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

Section 51945-4 (51945-4)

Topcare

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

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

Purposes

Lice Treatment

Warnings

For external use only

Directions

Important: Read warnings before use

Adults and children 2 years and over

Do Not Use (Do not use)

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

Package Insert

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

Active Ingredient

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Other Information

do not freeze

store at controlled room temperature 20°-25°C (68°-77°F)

see package insert for additional information

Inactive Ingredients

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

Additional 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

Questions Or Comments? (Questions or comments?)

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

When Using This Product (When using this product)

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 (Stop and ask a doctor if)

breathing difficulty occurs

eye irritation occurs

skin or scalp irritation continues or infection occurs

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Ask Doctor Before Use If You Are (Ask doctor before use if you are)

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

Remove Lice and Their Eggs (nits) (Remove lice and their eggs (nits))

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


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