Label: XTRACARE ANTI-DANDRUFF HAIR CLEANSE FOR NORMAL HAIR- pyrithione zinc shampoo

  • NDC Code(s): 58503-028-01
  • 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 12, 2019

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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 HAIR CLEANSE  FOR NORMAL HAIR
    pyrithione zinc shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-028
    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)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    .BETA.-D-GLUCOPYRANOSE (UNII: J4R00M814D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-028-01400 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 finalpart358H10/09/2013
    Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-028)
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