AXE ANTIDANDRUFF STYLING- pyrithione zinc cream

Axe by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Pyrithione Zinc (0.2%)

PURPOSE

Purpose

Anti-dandruff

INDICATIONS & USAGE

Use

Helps prevent and control recurrence of 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 this and all drugs out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Apply to affected areas one to four times daily or as directed by a doctor.

Massage product into scalp to relieve dryness and itch.

Style hair as usual.​

INACTIVE INGREDIENT

Inactive Ingredients:

Water (Aqua), Cetearyl Alcohol, Steareth-20, Propylene Glycol, PPG-5-Ceteth-20, Isopropyl Palmitate, VP/VA Copolymer, Polyquaternium-68, Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer, Fragrance (Parfum), Steareth-2, Glycerin, DMDM Hydantoin, PEG-100 Stearate, Sodium Polyacrylate, Hydrogenated Polydecene, Butylene Glycol, Trideceth-6, Iodopropynyl Butylcarbamate, Blue 1 (CI 42090)

QUESTIONS

Questions, Comments?

Call 1-800-372-6389

PDP

INGREDIENTS AND APPEARANCE

AXE  ANTIDANDRUFF STYLING
pyrithione zinc cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64942-1289
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Pyrithione Zinc (UNII: R953O2RHZ5) (Pyrithione Zinc - UNII:R953O2RHZ5)	Pyrithione Zinc	0.2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARETH-20 (UNII: L0Q8IK9E08)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
COPOVIDONE K25-31 (UNII: D9C330MD8B)
STEARETH-2 (UNII: V56DFE46J5)
GLYCERIN (UNII: PDC6A3C0OX)
DMDM HYDANTOIN (UNII: BYR0546TOW)
PEG-100 STEARATE (UNII: YD01N1999R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64942-1289-1	90 g in 1 TUBE
2	NDC: 64942-1289-2	18 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	02/19/2013

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

Establishment
Name	Address	ID/FEI	Business Operations
Thibiant International, Inc.		083913913	manufacture(64942-1289)