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Axe Freeze AntiDandruff

Dosage form: shampoo
Ingredients: Pyrithione Zinc 1mL in 100mL
Labeler: Conopco Inc. d/b/a Unilever
NDC Code: 64942-1185

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.

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
QUESTIONS/COMMENTS?
1-800-450-7580

PDP 12 oz front

PDP 12 oz back
AXE  FREEZE ANTIDANDRUFF
pyrithione zinc shampoo
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64942-1185
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Pyrithione Zinc (Pyrithione) Pyrithione Zinc1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM LAURETH SULFATE 
COCAMIDOPROPYL BETAINE 
SODIUM CHLORIDE 
CARBOMER HOMOPOLYMER TYPE C 
GLYCOL STEARATE 
MENTHOL 
DMDM HYDANTOIN 
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) 
TEA-DODECYLBENZENESULFONATE 
CITRIC ACID MONOHYDRATE 
IODOPROPYNYL BUTYLCARBAMATE 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
PPG-9 
MICA 
TITANIUM DIOXIDE 
FD&C BLUE NO. 1 
D&C RED NO. 33 
Packaging
#Item CodePackage Description
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/FEIOperations
Unilever Supply Chain Co. d/b/a Unilever043510056manufacture

Revised: 06/2011
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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