Label: ZINC- zinc soap soap

  • 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 April 2, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient(s)

    Pyrithione Zinc 2.0%

  • Purpose

    Dandruff, Seborrheic dermatitis

  • Warnings

    For external use only

  • Do not use

    Avoid contact with eyes

  • WHEN USING

    When using this product Avoid contact with eyes. If contact occurs , rinse eyes thoroughly with water

  • STOP USE

    Stop Use and Ask a Doctor if

    Condition worsens or does not improve after regular use as directed

  • 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

  • Directions

    Use on affected areas in place of your regular soap.

    For best results use at least twice a week or as directed by a doctor.

    Work up a lather using warm water and massage into affected areas.

    Rinse well.

  • Other information

    Store at room temperature

  • Inactive ingredients

    Sodium Palmitate , Sodium Palm Kernelate , Water , Glycerin ,Tetrasodium EDTA . Aloe Vera Extract

  • INDICATIONS & USAGE

    Controls , reduces , and helps stop the symptoms of dandruff and seborrheic dermatitis

  • Package Label - Principal Display Panel

    120g 78565-007-01

    120g 78565-007-01

  • INGREDIENTS AND APPEARANCE
    ZINC 
    zinc soap soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78565-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5) PYRITHIONE ZINC2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM PALMITATE (UNII: JQ43KP6296)  
    SODIUM PALM KERNELATE (UNII: 6H91L1NXTW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    ColorpinkScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78565-007-02240 g in 1 BOX; Type 0: Not a Combination Product12/25/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H12/15/2021
    Labeler - Meixin Beauty & Health Care Products Co., Ltd. (421458605)
    Establishment
    NameAddressID/FEIBusiness Operations
    Meixin Beauty & Health Care Products Co., Ltd.421458605manufacture(78565-007)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!