GOOD SENSE LICE KILLING CREME RINSE- permethrin lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
PERMETHRIN (UNII: 509F88P9SZ) (PERMETHRIN - UNII:509F88P9SZ)
Available from:
L. Perrigo Company
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Lice treatment treats head lice
Authorization status:
Abbreviated New Drug Application
Authorization number:
0113-1910-16

GOOD SENSE LICE KILLING CREME RINSE- permethrin lotion

L. Perrigo Company

----------

Perrigo Lice Killing Creme Rinse Drug Facts

Active ingredient (in each fluid ounce)

Permethrin 280 mg (1%)

Purpos e

Lice treatment

Us e

treats head lice

Warnings

For external use only

Do not use

See your doctor.

Ask a doctor before use if you are

When using this product

Stop use and see a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

on children under 2 months of age

near the eyes

inside the nose, ear, mouth, or vagina

on lice in eyebrows or eyelashes.

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

keep eyes tightly closed and protect eyes with a washcloth or towel

if product gets into the eyes, immediately flush with large amounts of water

scalp itching or redness may occur

breathing difficulty occurs

eye irritation occurs

skin or scalp irritation continues or infection occurs

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

Directions

Ins pect

Treat

Remove Lice/Nits

Other information

all household members should be checked by another person for lice and/or nits (eggs)

use a magnifying glass in bright light to help you see the lice and nits (eggs)

use a tool, such as a comb or two unsharpened pencils to lift and part the hair

look for tiny nits near the scalp, beginning at the back of the neck and behind the ears

small sections of hair (1-2 inches wide) should be examined at a time

unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.

if either lice or nits (eggs) are found, treat with the creme rinse

wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner

or a conditioner alone since this may decrease the activity of the creme rinse. Rinse with water.

towel dry hair so it is damp but not wet

shake the bottle well

completely saturate the hair and scalp with the creme rinse. Begin to apply the creme rinse behind

the ears and at the back of the neck.

keep the creme rinse out of the eyes. Protect the eyes with a washcloth or towel.

leave the creme rinse on the hair for 10 minutes, but no longer

rinse with warm water

towel dry hair and comb out tangles

if live lice are seen seven days or more after the first treatment, a second treatment should be

given

remove nits by combing the hair with the special small tooth comb provided. Remaining nits may

be removed by hand (using a throw-away glove), or cutting the nits out.

use the nit comb provided and make sure the hair remains slightly damp while removing nits

if the hair dries during combing, dampen it slightly with water

part the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2

hours).

start at the top of the head on the section you have picked

with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as

possible and comb with a firm, even motion away from the scalp to the end of the hair.

use clips to pin back each strand of hair after you have combed out the nits

clean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away

the tissue in a sealed plastic bag to prevent the lice from coming back.

after combing, recheck the entire head for nits and repeat combing if necessary

check the affected head daily to remove any nits that you might have missed

Inactive ingredients

abies balsamea (balsam canada) extract, anhydrous citric acid, butylparaben, ceteth-10, cetyl alcohol,

ethylparaben, FD&C yellow no. 6, fragrance, hydrolyzed animal protein, hydroxyethyl cellulose,

isopropyl alcohol, methylparaben, phenoxyethanol, propylene glycol, propylparaben, purified water,

stearalkonium chloride

Questions or comments?

1-800-719-9260

Consumer Information

Permethrin Lotion, 1%

Lice Treatment Creme Rinse

THE FACTS OF LICE

Please read all information before using Lice Treatment Creme Rinse.

If you or a member of your household has head lice, don’t panic. Keep calm.

Anyone can get head lice - it has nothing to do with cleanliness or poor hygiene. Head lice are

treatable and very rarely cause serious health problems.

What are head lice?

What are nits?

Because nits (eggs) hatch in about one week, all nits must be removed to stop lice.

How do head lice spread?

How do you know if you have lice?

read all the directions and warnings in the Consumer Information Insert before use. Keep the

carton. It contains important information.

store at 20 to 25°C (68 to 77°F)

head lice are small insects that live and feed on the human scalp

they may get as big as sesame seeds and are brown

lice do not fly or jump from one person to another. They can only crawl.

nits are lice eggs laid on the hair near the scalp. One louse may lay over 100 nits.

nits are oval shaped, tiny and greyish-white

they are attached to hair with a waterproof glue-like substance that cannot be washed out or blown

away

head lice spread easily from close head-to-head or hand-to-head contact with persons who have

lice

they may also spread by sharing hats, helmets, scarves, headphones, brushes, combs, bedding and

clothing

itching is the most common symptom

scratching behind the ears or the back of the neck is a sign that you should check for head lice

How do you prevent the spread of lice?

How to use the creme rinse

I. Inspect

If you suspect head lice - check. Head lice may be hard to locate because they avoid light. Nits are easier to

see.

II. Treat

scabs or blood spots may be seen

do not share or borrow personal items like combs, brushes, or headbands

do not share or borrow hats, sweaters, coats, scarves, helmets, headphones, pillows or stuffed

animals

store hats in coat sleeves and hang coats separately, so that they do not touch other people’s hats

and coats

wash under fingernails when you first see lice or nits (eggs)

check your child’s head daily when you hear of a lice outbreak in day care or school

all household members should be checked by another person for lice and/or nits (eggs)

use a magnifying glass in bright light to help you see the lice and nits (eggs)

use a tool, such as a comb or two unsharpened pencils to lift and part the hair

look for tiny nits near the scalp, beginning at the back of the neck and behind the ears

small sections of hair (1-2 inches wide) should be examined at a time

unlike dandruff, nits stick to the hair. Dandruff should move when lightly touched.

if either lice or nits (eggs) are found, treat with the creme rinse

III. Remove Lice/Nits

Treatment kills lice but does not remove the nits.

wash hair with a shampoo without conditioner. Do not use a shampoo that contains a conditioner

or a conditioner alone since this may decrease the activity of the creme rinse. Rinse with water.

towel dry hair so it is damp but not wet

shake the bottle well

completely saturate the hair and scalp with the creme rinse. Begin to apply the creme rinse behind

the ears and at the back of the neck.

keep the creme rinse out of the eyes. Protect the eyes with a washcloth or towel.

leave the creme rinse on the hair for 10 minutes, but no longer

rinse with warm water

towel dry hair and comb out tangles

if live lice are seen seven days or more after the first treatment, a second treatment should be

given

remove nits by combing the hair with the special small tooth comb provided. Remaining nits may

be removed by hand (using a throw-away glove), or cutting the nits out.

use the nit comb provided and make sure the hair remains slightly damp while removing nits

if the hair dries during combing, dampen it slightly with water

part the hair into 4 sections. Work on one section at a time. Longer hair may take more time (1-2

hours).

start at the top of the head on the section you have picked

with one hand, lift a 1-2 inch wide strand of hair. Get the teeth of the comb as close to the scalp as

possible and comb with a firm, even motion away from the scalp to the end of the hair.

use clips to pin back each strand of hair after you have combed out the nits

clean the comb completely as you go. Wipe the nits from the comb with a tissue and throw away

the tissue in a sealed plastic bag to prevent the lice from coming back.

after combing, recheck the entire head for nits and repeat combing if necessary

check the affected head daily to remove any nits that you might have missed

IV. Clean home and personal items

After using the creme rinse, it is very important to clean personal items and your home to prevent the

spread of lice. Nits may live away from the human head for about 7-12 days. Lice may live away from the

human head for about 1 day.

Warnings

For external use only

Do not use

all personal head gear (hats, hair ribbons, etc.), scarves, coats, towels and bed linens should be

washed in hot water (above 130°F), then dried in the dryer using the hottest cycle for at least 20

minutes

personal combs, including nit combs, and brushes should be soaked in hot water (above 130°F) for

at least 10 minutes

personal articles such as clothing, bedspreads, blankets, pillows or stuffed animals that cannot be

washed should be dry-cleaned or sealed tightly in a plastic bag for a period of at least 4 weeks.

Items should be taken out of the plastic bag outdoors and shaken out very hard before using again.

for anything you cannot wash, dry-clean or store in a plastic bag, spray with lice control spray.

vacuum everywhere. Vacuum all carpets, mattresses, upholstered furniture and car seats that may

have been used by infested household members.

on children under 2 months of age

near the eyes

Ask a doctor before use if you are

When using this product

Stop use and see a doctor if

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

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

Question or comments?

1-800-719-9260

Distributed By

Perrigo®

Allegan, MI 49010

:95500 00 J2

Principal Display Panel

Permethrin Lotion 1%

Lice Treatment

Lice Killing Creme Rinse

With a Single Application

Kills Lice & Their Eggs

Prevents Reinfestation for 14 Days

SAFE

Approved for Use on Children Over 2 Months of Age

1 Bottle Creme Rinse & 1 Nit Removal Comb

Compare to active ingredient of Nix

Creme Rinse

100% SATISFACTION GUARANTEED

inside the nose, ear, mouth, or vagina

on lice in eyebrows or eyelashes. See your doctor.

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

keep eyes tightly closed and protect eyes with a washcloth or towel

if product gets into the eyes, immediately flush with large amounts of water

scalp itching or redness may occur

breathing difficulty occurs

eye irritation occurs

skin or scalp irritation continues or infection occurs

2 FL OZ (59 mL)

GOOD SENSE LICE KILLING CREME RINSE

permethrin lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:0 113-19 10

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

PERMETHRIN (UNII: 50 9 F8 8 P9 SZ) (PERMETHRIN - UNII:50 9 F8 8 P9 SZ)

PERMETHRIN

1 mg in 10 0 mL

Inactive Ingredients

Ingredient Name

Stre ng th

BALSAM FIR LEAFY TWIG (UNII: H1TFV1454Z)

L. Perrigo Company

ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

BUTYLPARABEN (UNII: 3QPI1U3FV8 )

CETETH-10 (UNII: LF9 X1PN3XJ)

CETYL ALCO HO L (UNII: 9 36 JST6 JCN)

ETHYLPARABEN (UNII: 14255EXE39 )

FD&C YELLO W NO . 6 (UNII: H77VEI9 3A8 )

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

WATER (UNII: 0 59 QF0 KO0 R)

STEARALKO NIUM CHLO RIDE (UNII: 0 OUO26 BB8 8 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:0 113-19 10 -16

1 in 1 CARTON

0 7/24/20 19

1

59 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 0 9 0

0 7/24/20 19

Labeler -

L. Perrigo Company (006013346)

Revised: 7/2019

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