Label: XTRACARE DANDRUFF HAIR WASH- salicylic acid shampoo
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Contains inactivated NDC Code(s)
NDC Code(s): 58503-053-01 - Packager: China Ningbo Shangge Cosmetic Technology Corp.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 13, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
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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
- INACTIVE INGREDIENT
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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
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INGREDIENTS AND APPEARANCE
XTRACARE DANDRUFF HAIR WASH
salicylic acid shampooProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58503-053 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:58503-053-01 325 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 - China Ningbo Shangge Cosmetic Technology Corp. (529287434) Establishment Name Address ID/FEI Business Operations China Ningbo Shangge Cosmetic Technology Corp 529287434 manufacture(58503-053)