MEDI AND LICE LICE KILLING- piperonyl butoxide, pyrethrum extract shampoo

medi and lice lice killing by

Drug Labeling and Warnings

medi and lice lice killing by is a Otc medication manufactured, distributed, or labeled by Bicooya Cosmetics Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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, PEG-25, fragrance, hydrogenated castor oil, water, xanthan gum

Questions?

1-888-263-3084

Principal Display Panel

Lice Killing Shampoo

Lice Treatment

Compare to RID® in active ingredients

Lice Killing Shampoo

59 ml

INGREDIENTS AND APPEARANCE

MEDI AND LICE LICE KILLING 
piperonyl butoxide, pyrethrum extract shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58180-220
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
BENZYL ALCOHOL (UNII: LKG8494WBH)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics
Color	YELLOW (cloudy to transparent, cream to straw)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58180-220-01	1 in 1 CARTON	05/24/2016
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	05/24/2016

Labeler - Bicooya Cosmetics Limited (421310774)

Registrant - Bicooya Cosmetics Limited (421310774)

Establishment
Name	Address	ID/FEI	Business Operations
Bicooya Cosmetics Limited		421310774	manufacture(58180-220)