Label: XTRACARE ANTI-DANDRUFF CONDITIONER COCONUT AND SHEA BUTTER- pyrithione zinc lotion/shampoo

  • NDC Code(s): 57337-025-01
  • Packager: Rejoice International Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 28, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient                              Purpose

    Pyrithione zinc 0.5% .................. Anti-dandruff

  • PURPOSE

    XtraCare Anti-Dandruff Shampoo + pyrithione zinc

    nourishing coconut & shea butter

    fight flakes leaving hair healthy & shiny

  • 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

    Uses helps prevent recurrence of flaking and itching associated with dandruff.

    Gentle enough for everyday use. For best results, use with XtraCare nourishing coconut & shea butter conditioner.

  • WARNINGS

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    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 INGREDIENT

    Inactive Ingredients

    water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, cocamide MEA, lauryl methyl gluceth-10, glycerin, carbomer, DMDM hydantoin, fragrance, triethanolamine, disodium EDTA, cocos nucifera (coconut) fruit extract, shea nut butter.

  • OTHER SAFETY INFORMATION

    Other information

    store at 20°C to 25°C (68° to 77°F)

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    XTRACARE ANTI-DANDRUFF CONDITIONER  COCONUT AND SHEA BUTTER
    pyrithione zinc lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57337-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC20 mg  in 400 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    POLYQUATERNIUM-37 (3000 MPA.S) (UNII: HU373G0YSU)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    TRIDECETH-6 (UNII: 3T5PCR2H0C)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57337-025-01400 mg in 1 BOTTLE; Type 0: Not a Combination Product10/09/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03210/09/2013
    Labeler - Rejoice International Inc. (078741245)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(57337-025)
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