CLEAN APPLE- pyrithione zinc shampoo

Clean Apple by

Drug Labeling and Warnings

Clean Apple by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc, Vi-Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Pyrithione zinc 1%

Purpose

Anti-dandruff

Use

helps prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only

When using this product

• do not get into 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 as directed

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• shake well
• for maximum dandruff control, use every time you shampoo
• wet hair, massage onto scalp, rinse, repeat if desired
• for best results use at least twice a week or as directed by a doctor

Inactive ingredients

water, sodium lauryl sulfate, sodium laureth sulfate, glycol distearate, sodium chloride, zinc carbonate, sodium xylenesulfonate, amodimethicone, cocamidopropyl betaine, fragrance, sodium benzoate, guar hydroxypropyltrimonium chloride, magnesium carbonate hydroxide, methylchloroisothiazolinone, methylisothiazolinone, blue 1, yellow 5, citric acid

Questions

Call 1-888-287-1915

SPL UNCLASSIFIED SECTION

Clean Apple
2 in 1 Pyrithione Zinc Dandruff Shampoo & Conditioner

Satisfaction guaranteed - For questions or comments please call 1-888-287-1915

*This product is not manufactured or distributed by Procter & Gamble, distributor of Head & Shoulders Green Apple 2 in 1 Dandruff Shampoo & Conditioner.

Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716

Principal display panel

Equate

Compare to Head &  Shoulders Active Ingredient*

Clean Apple 2 in 1 Pyrithione Zinc Dandruff

Shampoo & Conditioner

• Helps cleanse scalp & hair with a refreshing apple scent
• Helps relieve itching and flaking associated with dandruff

33.8 FL OZ (1 L)

612.001/612AC

INGREDIENTS AND APPEARANCE

CLEAN APPLE 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-898
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC CARBONATE (UNII: EQR32Y7H0M)
SODIUM XYLENESULFONATE (UNII: G4LZF950UR)
AMODIMETHICONE (800 CST) (UNII: 363Z2T48P7)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
MAGNESIUM CARBONATE HYDROXIDE (UNII: YQO029V1L4)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-898-35	701 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/21/2013
2	NDC: 49035-898-39	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/21/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	11/21/2013

Labeler - Wal-Mart Stores, Inc (051957769)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(49035-898)