Label: SUDOCREM SKIN PROTECTANT- zinc oxide cream

  • NDC Code(s): 84589-002-10, 84589-002-12, 84589-002-25, 84589-002-40, view more
    84589-002-60
  • Packager: LEDA INNOVATIONS USA, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 29, 2024

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  • Drug Facts

  • Active ingredient

    Zinc oxide (15.29%)

  • Purpose

    Skin protectant

  • Uses

    • Helps treat and prevent Diaper Rash and Incontinence Dermatitis
    • Protects chafed skin and minor skin irritations due to diaper rash and helps protect from wetness
  • Warnings

    For external use only.

    When using this product

    • do not get into eyes

    Stop use and ask a doctor if

    • conditions worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Apply as needed
    • For diaper rash, change wet and soiled diapers promptly, cleanse the diaper area, and allow it to dry. Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
  • Other information

    • Store at room temperature between 15C and 30C (59F to 86F)
    • Do not use if safety seal is broken or missing
  • Inactive ingredients

    beeswax, benzyl alcohol, benzyl benzoate, benzyl cinnamate, BHA, cetyl esters, cetyl alcohol, citric acid, lanolin, lavender oil, linalyl acetate, liquid paraffin, microcrystalline wax, paraffin wax, propylene glycol, sodium benzoate, sorbitan sesquioleate, stearic acid, water

  • Product Packaging

    1

  • INGREDIENTS AND APPEARANCE
    SUDOCREM SKIN PROTECTANT 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84589-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE152.9 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LINALYL ACETATE (UNII: 5K47SSQ51G)  
    BENZYL CINNAMATE (UNII: V67O3RO97U)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84589-002-101 in 1 BLISTER PACK08/06/2024
    110 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:84589-002-6060 g in 1 JAR; Type 0: Not a Combination Product08/06/2024
    3NDC:84589-002-12125 g in 1 JAR; Type 0: Not a Combination Product08/06/2024
    4NDC:84589-002-25250 g in 1 JAR; Type 0: Not a Combination Product08/06/2024
    5NDC:84589-002-40400 g in 1 JAR; Type 0: Not a Combination Product08/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01608/06/2024
    Labeler - LEDA INNOVATIONS USA, INC. (779937036)
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