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
controls scalp itching and flaking associated with dandruff

Warnings
For external use only

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions
·  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, Glycol Distearate, Menthol, DMDM Hydantoin,  Guar Hydroxypropyltrimonium Chloride, TEA-Dodecylbenzenesulfonate,  Citric Acid, Iodopropynyl Butylcarbamate, Methylchloroisothiazolinone, Methylisothiazolinone,  PPG-9, Mica (CI 77019), Titanium Dioxide (CI 77891),  Blue 1 (CI 42090), Red 33 (CI 17200)

theaxeeffect.com
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PDP 12 oz front
Axe Freeze AntiDandruff Shampoo 12oz front PDP

PDP 12 oz back
Axe Freeze AntiDandruff Shampoo 12oz back PDP
AXE  FREEZE ANTIDANDRUFF
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1185
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione - UNII:6GK82EC25D) Pyrithione Zinc1 mL  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)  
GLYCOL STEARATE (UNII: 0324G66D0E)  
MENTHOL (UNII: L7T10EIP3A)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
PPG-9 (UNII: I29VQH0G0B)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64942-1185-1355 mL in 1 CONTAINER
2NDC:64942-1185-250 mL in 1 CONTAINER
3NDC:64942-1185-3443 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

Revised: 6/2011
Document Id: 8eaeaeac-b058-428b-abb6-4ad1f01ed950
Set id: f4f3add3-9253-42e6-afe2-565c7ee01585
Version: 1
Effective Time: 20110602
 
Conopco Inc. d/b/a Unilever