Label: HERKLIN LICE TREATMENT- piperonyl butoxide, pyrethrum extract shampoo
- NDC Code(s): 75940-192-09
- Packager: MarcasUSA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 16, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Inactive Ingredients
- Purpose
- Uses
-
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 us 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 in eyes, flush with water right away
- scalp itching or redness may occur.
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Directions
- 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, beginin 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.
- 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 head. Longer hair may take 1 to 2 hours.
- life 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 froom coming back.
- after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.
- 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: aska doctor
- Other Information
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Consumer Information
Kills Lice & Eliminates Nits in 3 simple steps
STEP 1: APPLY • APLIQUE
Apply shampoo on dry hair for 10 minutes.
STEP 2: REMOVE • RETIRE
Remove lice and nits with comb provided.
STEP 3: REPEAT • REPITA
Repeat treatment 1 week later.
Detailed Instructions Inside
BILINGUAL HOW-TO VIDEOS
Visit HERKLINE USA on YouTube for step-by-step videos.
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Principal Display Panel - 236 mL Bottle Carton
MAXIMUM STRENGTH
• PROUDLY SERVING FAMILIES FOR •
38
YEARSHERKLIN®
LICE TREATMENTPiperonyl butoxide 4%
Pyrethrum extract (0.33% pyrethrins)Kills Lice &
Eliminates Nits*Effective & safe for ages 2+
NEED HELP? •
Toll
Free
(844) HERKLIN
(437-5546)INCLUDES:
Shampoo, Lice
& Nit CombLICE COMB INCLUDED
2 fl oz (59 mL)
*Proper use of nit comb removes nits
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INGREDIENTS AND APPEARANCE
HERKLIN LICE TREATMENT
piperonyl butoxide, pyrethrum extract shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75940-192 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE 4 g in 100 mL PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT 0.33 g in 100 mL Inactive Ingredients Ingredient Name Strength PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J) POLYQUATERNIUM-10 (125 MPA.S AT 2%) (UNII: L45WU8S981) ALCOHOL (UNII: 3K9958V90M) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75940-192-09 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/16/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part358G 07/16/2018 Labeler - MarcasUSA LLC (016139820) Registrant - MarcasUSA LLC (016139820) Establishment Name Address ID/FEI Business Operations Weeks & Leo Co.Inc 005290028 manufacture(75940-192)