EQUATE CLASSIC SPICE 2 IN 1 DANDRUFF- pyrithione zinc shampoo

Equate Classic Spice 2 in 1 Dandruff by

Drug Labeling and Warnings

Equate Classic Spice 2 in 1 Dandruff by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc, Apollo Health and Beauty Care Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Pyrithione Zinc 1%

Purpose

Anti-dandruff

Uses

to help prevent recurrence of flaking and itching 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.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

• for maximum dandruff control, use every time you shampoo
• wet hair, massage onto scalp and rinse
• repeat if desired

Inactive ingredients

Water (Aqua), Sodium Laureth Sulfate, Sodium Chloride, Cocamide MEA, Glycol Distearate, Dimethicone, Acrylates Copolymer, Glycerin, Cocamidopropyl Betaine, Fragrance (Parfum), Laureth-4, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Blue 1 (CI 42090), Red 33 (CI 17200).

Label Copy

INGREDIENTS AND APPEARANCE

EQUATE CLASSIC SPICE 2 IN 1 DANDRUFF 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-432
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1) (UNII: 74G4R6TH13)
GLYCERIN (UNII: PDC6A3C0OX)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LAURETH-4 (UNII: 6HQ855798J)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
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: 49035-432-12	399 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/27/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	04/27/2017

Labeler - Wal-Mart Stores Inc (051957769)

Registrant - Apollo Health and Beauty Care Inc. (201901209)

Establishment
Name	Address	ID/FEI	Business Operations
Apollo Health and Beauty Care Inc.		201901209	manufacture(49035-432)