XTRACARE DANDRUFF HAIR WASH- salicylic acid shampoo

XtraCare Dandruff Hair Wash by

Drug Labeling and Warnings

XtraCare Dandruff Hair Wash by is a Otc medication manufactured, distributed, or labeled by Rejoice International, China Ningbo Shangge Cosmetic Technology Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient                                Purpose

Salicylic Acid 3% ........................... Anti-dandruff

PURPOSE

Uses

for relief of flaking and itching due to dandruff and sebhorreic dermatitis, and to help prevent their recurrence

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

*compare to active ingredients in Selsun Blue® naturals dandruff shampoo

XtraCare® Dandruff Shampoo Salicylic Acid 3%

Controls Flakes & Itch

• Intensive Moisturizers
• Enriched with Vitamin B5

11 Fl Oz (325 mL)

WARNINGS

Warnings

For external use only

Ask a doctor before use if you have

• sebhorreic dermatitis in areas other than the scalp

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.

DOSAGE & ADMINISTRATION

Directions

• shampoo, then rinse thoroughly
• for best results, use at least twice a week or as directed by a doctor

INACTIVE INGREDIENT

Inactive Ingredients: water, sodium laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, cocamide MEA, fragrance, polyquaternium-10, disodium EDTA, citric acid, benzyl alcohol, panthenol (pro-vitamin B5), triclosan, fd&c blue no.1

OTHER SAFETY INFORMATION

Other Information store at room temperature

Questions/Comments? 1-855-345-5575

*This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Selsun Blue® Naturals Dandruff Shampoo.

DISTRIBUTED BY:

REJOICE INTERNATIONAL INC

NORTHVILLE, MI 48168, USA

MADE IN CHINA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRACARE DANDRUFF HAIR WASH 
salicylic acid shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-053
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 g  in 325 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
BENZYL ALCOHOL (UNII: LKG8494WBH)
PANTHENOL (UNII: WV9CM0O67Z)
TRICLOSAN (UNII: 4NM5039Y5X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-053-01	325 g in 1 BOTTLE; Type 0: Not a Combination Product	02/05/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	02/05/2014

Labeler - Rejoice International (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
China Ningbo Shangge Cosmetic Technology Corp		529287434	manufacture(57337-053)