Label: DIABETIC SKIN CARE FORMULA- zinc acetate soap

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 31, 2020

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  • PURPOSE

    Assist in wound healing

  • ACTIVE INGREDIENT

    Zinc Acetate .............25%

  • INACTIVE INGREDIENTS

    CETEARYL ALCOHOL
    POLYOXYL 20 CETOSTEARYL ETHER
    DI-C12-15 ALKYL FUMARATE
    PETROLATUM
    MINERAL OIL
    SHEA BUTTER
    DIMETHICONE
    CETYLHYDROXYPROLINE PALMITAMIDE
    ALPHA LIPOIC ACID
    WATER
    CARBOMER HOMOPOLYMER
    NIACINAMIDE
    TOCOPHERYL ACETATE
    SOYBEAN

    HYALURONIC ACID
    HYALURONATE SODIUM
    DEXTROSE
    PANTHENOL
    PYRIDOXINE HYDROCHLORIDE
    VITAMIN A ACETATE
    VITAMIN D

  • INDICATIONS AND USAGE

    Treats and prevents skin breakdown due to circulation and nutrition problems

  • DOSAGE & ADMINISTRATION

    Apply to affected area at least twice daily for treatment and prevention

  • WARNINGS

    For external use only.

    Avoid contact with eyes.

    In case of indegestion contact a poison control center or physician immediately

    If condition worsens or does not improve within 7 days, consult physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PACKAGE LABEL

    LABEL

  • INGREDIENTS AND APPEARANCE
    DIABETIC SKIN CARE FORMULA 
    zinc acetate soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70334-152
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC ACETATE (UNII: FM5526K07A) (ZINC CATION - UNII:13S1S8SF37) ZINC ACETATE0.0025 mg  in 1 mg
    Inactive Ingredients
    Ingredient NameStrength
    DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    WATER (UNII: 059QF0KO0R)  
    .ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    DEXTROSE (UNII: IY9XDZ35W2)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70334-152-60250 mg in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/31/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/31/2016
    Labeler - K5 BRANDS, LLC (080076713)
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