HERKLIN LICE TREATMENT- piperonyl butoxide, pyrethrum kit

HERKLIN Lice Treatment by

Drug Labeling and Warnings

HERKLIN Lice Treatment by is a Otc medication manufactured, distributed, or labeled by Estrella Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Piperonyl butoxide 4% 

Pyrethrum extract (equivalent to 0.33% pyrethrins)

Purposes

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 in 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

• 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 bact 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 thorughly 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 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 strandd 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

• do not freeze
• store at controlled room temperature. 20 °C to 25 °C (68 °F to 77 °F)
• Questions or comments call (XXX) XXX-XXXX
• see package insert for additional information

Inactive ingredients

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

HERKLIN Lice Treatment Kit (

72902-001-02)

INGREDIENTS AND APPEARANCE

HERKLIN LICE TREATMENT 
piperonyl butoxide, pyrethrum kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72902-001

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72902-001-02	1 in 1 KIT	04/01/2019

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	59 mL

Part 1 of 1

HERKLIN LICE TREATMENT 
piperonyl butoxide, pyrethrum shampoo

Product Information
Item Code (Source)	NDC: 72902-000
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	3.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PEG-25 HYDROGENATED CASTOR OIL (UNII: 0ZNO9PJJ9J)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72902-000-02	1 in 1 CARTON
1		59 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	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358G	04/01/2019

Labeler - Estrella Brands, LLC (116929354)