AXE FREEZE ANTIDANDRUFF- pyrithione zinc shampoo 
Conopco Inc. d/b/a Unilever

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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Axe Freeze Anti-Dandruff shampoo+conditioner

Active Ingredient
Pyrithione Zinc (1.0%)

Purpose

Anti-dandruff

Use helps control scalp itching and flaking associated with dandruff.

Warnings
For external use only

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center Right Away.

Avoid contact with eyes.  Product contains menthol.  If you experience discomfort, please stop use.

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.

Direction

·  Squeeze. Lather. Rinse
·  For best results, use at least twice a week or as directed by a doctor.

Inactive ingredients
Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Fragrance (Parfum), Carbomer, Dimethiconol, Menthol, DMDM Hydantoin, Citric Acid, Guar Hydroxypropyltrimonium Chloride, TEA-Dodecylbenzenesulfonate, Butylene Glycol, Iodopropynyl Butylcarbamate, Propylene Glycol, PPG-9, Methylisothiazolinone, Methylchloroisothiazolinone, Blue 1 (CI 42090), Yellow 5 (CI 19140).

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AXE  FREEZE ANTIDANDRUFF
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1357
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) Pyrithione Zinc1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MENTHOL (UNII: L7T10EIP3A)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
TRIETHANOLAMINE DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PPG-9 (UNII: I29VQH0G0B)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64942-1357-1355 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358H08/02/2009
Labeler - Conopco Inc. d/b/a Unilever (001375088)
Establishment
NameAddressID/FEIBusiness Operations
Unilever Supply Chain Co. d/b/a Unilever043510056manufacture(64942-1357)

Revised: 4/2014
Document Id: 1a33afeb-9d19-409b-8f93-537c32bff8f6
Set id: df838226-0534-4015-81fb-6a19e53b87c3
Version: 1
Effective Time: 20140424
 
Conopco Inc. d/b/a Unilever