Label: MCKESSON SKIN PROTECTANT- zinc oxide cream

  • NDC Code(s): 68599-5312-1, 68599-5312-2, 68599-5312-6
  • Packager: McKesson Medical-Surgical Inc.
  • 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 January 14, 2021

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  • ACTIVE INGREDIENT

    Active ingredient

    Zinc Oxide 5.0%

  • PURPOSE

    Purpose

    Anorectal

  • INDICATIONS & USAGE

    Uses

    Provides temporary relief of itching and discomfort in the perineal area

  • WARNINGS

    Warnings

    For external use only.

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

    Do not exceed the recommended daily dosage unless directed by a physician

    In case of bleeding, consult a physician immediately

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions

    When practical, clean the affected area by patting or blotting with an appropriate cleaning pad.

    Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

    Apply Skin Protectant Cream externally to affected area.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Purified Water, Cyclotetrasiloxane, Isopropyl Palmitate, Ethylhexyl Palmitate, Glycerin, Cyclopentasiloxane, Polyglyceryl-4 Isostearate,
    Cetyl PEG/PPG-10/1 Dimethicone, Hexyl Laurate, Cetyl Dimethicone, Dimethicone, Tocopherol (Vitamin E), Zea Mays Oil, Retinyl Palmitate (Vitamin A), Cholecalciferol (Vitamin D3), Beeswax, Hydrogenated Castor Oil, Sodium Chloride, DMDM Hydantoin, Iodopropynyl Butylcarbamate

  • QUESTIONS

    Questions? Call 1-800-777-4908

  • PRINCIPAL DISPLAY PANEL

    NDC 68599-5312-6

    McKesson

    Skin

    Protectant

    Cream

    Contains Zinc Oxide

    with Vitamins A, D, and E

    NET CONTENTS

    6 oz

    (177 ml)

    MFR # 53-23103

    53-23103 Each

  • INGREDIENTS AND APPEARANCE
    MCKESSON SKIN PROTECTANT 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68599-5312
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CORN OIL (UNII: 8470G57WFM)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    HEXYL LAURATE (UNII: 4CG9F9W01Q)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68599-5312-124 in 1 CASE10/25/201801/16/2019
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:68599-5312-224 in 1 CASE10/25/201801/16/2019
    2207 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3NDC:68599-5312-624 in 1 CASE10/25/2018
    3117 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/24/2014
    Labeler - McKesson Medical-Surgical Inc. (023904428)
    Establishment
    NameAddressID/FEIBusiness Operations
    Central Solutions007118524manufacture(68599-5312)
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