AXE FREEZE ANTIDANDRUFF- pyrithione zinc shampoo

Axe by

Drug Labeling and Warnings

Axe by is a Otc medication manufactured, distributed, or labeled by Conopco Inc. d/b/a Unilever, Unilever Supply Chain Co. d/b/a Unilever. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient
Pyrithione Zinc (1.0%)

PURPOSE

Purpose
Anti-dandruff

INDICATIONS & USAGE

Use
controls scalp itching and flaking associated with dandruff

WARNINGS

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.

DOSAGE & ADMINISTRATION

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

INACTIVE INGREDIENT

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)

QUESTIONS

theaxeeffect.com
QUESTIONS/COMMENTS?
1-800-450-7580

PRINCIPAL DISPLAY PANEL

PDP 12 oz front

PRINCIPAL DISPLAY PANEL

PDP 12 oz back

INGREDIENTS AND APPEARANCE

AXE  FREEZE ANTIDANDRUFF
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64942-1185
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione - UNII:6GK82EC25D)	Pyrithione Zinc	1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64942-1185-1	355 mL in 1 CONTAINER
2	NDC: 64942-1185-2	50 mL in 1 CONTAINER
3	NDC: 64942-1185-3	443 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	08/02/2009

Labeler - Conopco Inc. d/b/a Unilever (001375088)

Establishment
Name	Address	ID/FEI	Business Operations
Unilever Supply Chain Co. d/b/a Unilever		043510056	manufacture