TOPCARE COMPLETE LICE TREATMENT- piperonyl butoxide, pyrethrum extract 
Topco Associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Topco Complete Lice Treatment Kit Drug Facts

Active ingredient

Piperonyl butoxide 4%

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purpose

Lice treatment

Uses

treats head, pubic (crab), and body lice

Warnings

For external use only

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.

Ask a doctor before use if you are

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

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 use 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 right away.

Directions

Shake well before using

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

store at 20°-25°C (68°-77°F)
keep carton for important product information
see package insert for additional information

Inactive ingredients

benzyl alcohol, C13-C14 isoparaffin, fragrance, polyoxyethylene (1,1,3,3-tetramethyl butyl) phenyl ether, water, xanthan gum

Questions or comments?

1-888-423-0139

Principal Display Panel

1-2-3 Step Lice Control System

Instrucciones En Español Incluidas

Complete Lice Treatment Kit

Step 1 Treat - Lice Killing Shampoo

Works fast to kill lice and eggs

Helps children return to school nit free

Step 2 Remove - Egg & Nit Combing Gel

Use after lice killing treatment to help prevent reinfestation

Makes egg & nit removal faster and easier

Step 3 Control - Bedding Spray

For bedding and furniture

Kills lice and their eggs on mattresses, furniture, car interiors and other non-washable items

Keep Out of Reach of Children

CAUTION:

See Back and Side Panels for Additional Information.

Compare to Rid® Lice Killing Shampoo active ingredients

1 Nit Comb Included

Complete Lice Treatment Kit Carton

Complete Lice Treatment Kit Carton

Complete Lice Treatment Kit Carton

TOPCARE COMPLETE LICE TREATMENT 
piperonyl butoxide, pyrethrum extract kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-173
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-173-241 in 1 CARTON; Type 0: Not a Combination Product11/07/200702/01/2014
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 118 mL
Part 21 BOTTLE 57 g
Part 1 of 2
TOPCARE LICE KILLING 
piperonyl butoxide, pyrethrum extract shampoo
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE4 mg  in 100 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT0.33 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Product Characteristics
ColorYELLOW (cloudy to transparent, cream to straw) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G11/07/200702/01/2014
Part 2 of 2
TOPCARE EGG AND NIT 
combing aid gel
Product Information
Route of AdministrationTOPICAL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
157 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other11/07/200702/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G11/07/200702/01/2014
Labeler - Topco Associates LLC (006935977)

Revised: 11/2017
 
Topco Associates LLC