Label: SKIN PROTECTANT CREAM 43% PETROLATUM- 43% petrolaum skin protectant cream

  • NDC Code(s): 60232-0021-4
  • Packager: Swiss-American CDMO, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2023

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  • Warnings

    For external use only. Avoid contact with the eyes. Stop use and ask physician if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Do not use on deep or puncture wounds, animal bites or serious burns.

  • Uses

    For the temporary protection of: diaper rash, minor: cuts, scrapes and burns. Temporarily protects and helps relieve chapped or cracked skin. Helps protect from drying effects of wind and cold weather.

  • DOSAGE & ADMINISTRATION

  • Keep out of reach of children

    Keep out of reach of children

  • Active Ingredients

    Petrolatum 43%   Skin Protectant

  • PURPOSE

  • Inactive Ingredients

    Purified Water, Hydroxylated Lanolin, PEG-30 Dipolyhydroxystearate, Sorbitan Sesquioleate, Mineral Oil, Glycerin, Steareth-20, Ozokerite Wax, Magnesium Sulfate, Aloe Barbadensis Leaf Juice, DMDM Hydantoin, Iodopropynyl Butylcarbamate

  • Labeling

    PL021 Artwork

  • INGREDIENTS AND APPEARANCE
    SKIN PROTECTANT CREAM 43% PETROLATUM 
    43% petrolaum skin protectant cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60232-0021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM43 g  in 1000 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    HYDROXYLATED LANOLIN (UNII: EOI0B9800C)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60232-0021-4118 g in 1 TUBE; Type 0: Not a Combination Product09/02/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01609/02/2013
    Labeler - Swiss-American CDMO, LLC (080170933)
    Registrant - Swiss-American CDMO, LLC (080170933)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO, LLC080170933manufacture(60232-0021)
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