Label: XTRACARE DANDRUFF HAIR WASH- salicylic acid shampoo

  • 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.

  • 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

    label image

  • INGREDIENTS AND APPEARANCE
    XTRACARE DANDRUFF HAIR WASH 
    salicylic acid shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-053
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 g  in 325 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-053-01325 g in 1 BOTTLE; Type 0: Not a Combination Product02/05/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H02/05/2014
    Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp529287434manufacture(58503-053)