Label: HERKLIN- piperonyl butoxide and pyrethrum extract shampoo
- NDC Code(s): 75940-171-04
- Packager: MarcusUSA
- 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 November 7, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
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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 in eyes, flush with water right away
- scalp itching or redness may occur
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Directions
- Important: Read warnings before use
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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
- 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.
- 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
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
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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
8 fl oz (236 mL)
*Proper use of nit comb removes nits.
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INGREDIENTS AND APPEARANCE
HERKLIN
piperonyl butoxide and pyrethrum extract shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75940-171 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Piperonyl butoxide (UNII: LWK91TU9AH) (Piperonyl butoxide - UNII:LWK91TU9AH) Piperonyl butoxide 40 mg in 1 mL Pyrethrum extract (UNII: ZUM06L90GV) (Pyrethrum extract - UNII:ZUM06L90GV) Pyrethrum extract 0.033 mg in 1 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:75940-171-04 1 in 1 CARTON 10/29/2017 1 236 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part358G 10/29/2017 Labeler - MarcusUSA (016139820) Establishment Name Address ID/FEI Business Operations Weeks & Leo Co.Inc 005290028 MANUFACTURE(75940-171)