MEDI AND LICE LICE KILLING- piperonyl butoxide, pyrethrum extract shampoo 
Bicooya Cosmetics Limited

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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Lice Killing Shampoo 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

Adults and children 2 years and over:

Inspect

Treat

Remove lice and their eggs (nits)

Other 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

Lice Killing Shampoo Carton
MEDI AND LICE LICE KILLING 
piperonyl butoxide, pyrethrum extract shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58180-220
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PIPERONYL BUTOXIDE (UNII: LWK91TU9AH) (PIPERONYL BUTOXIDE - UNII:LWK91TU9AH) PIPERONYL BUTOXIDE4 g  in 100 mL
PYRETHRUM EXTRACT (UNII: ZUM06L90GV) (PYRETHRUM EXTRACT - UNII:ZUM06L90GV) PYRETHRUM EXTRACT0.33 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
Product Characteristics
ColorYELLOW (cloudy to transparent, cream to straw) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58180-220-011 in 1 CARTON05/24/2016
159 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358G05/24/2016
Labeler - Bicooya Cosmetics Limited (421310774)
Registrant - Bicooya Cosmetics Limited (421310774)
Establishment
NameAddressID/FEIBusiness Operations
Bicooya Cosmetics Limited421310774manufacture(58180-220)

Revised: 5/2016
Document Id: b500912e-bb3e-44af-9ed2-8fbf52bc8c00
Set id: ccffcd64-1380-43d2-9fff-64f59f35a372
Version: 1
Effective Time: 20160524
 
Bicooya Cosmetics Limited