Label: BALMEX DIAPER RASH- zinc oxide cream

  • NDC Code(s): 52412-400-02, 52412-400-04, 52412-400-05, 52412-400-16
  • Packager: Randob Labs,Ltd.
  • 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 November 13, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Zinc Oxide 11.3%Skin protectant
  • Uses

    • Helps treat and prevent diaper rash
    • protects chafed skin due to diaper rash and helps seal out wetness
  • Warnings

    For external use only                

    When using this product

    • do not get into eyes.

    Stop use and ask a doctor 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 swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • change wet or soiled diapers promptly, cleanse the diaper area, and allow to dry
    • apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged
  • Other information

    • do not use if quality seal is broken
    • see bottom of carton and or top of tube for lot number and expiration date
  • INACTIVE INGREDIENT

    Inactive ingredients Beeswax, benzoic acid, dimethicone, fragrance, glycine soja (soybean) oil, magnesium aspartate, methylparaben, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europea (olive) leaf extract, panthenol, potassium aspartate, potassium hydroxide, propylparaben, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water (245-230)

  • Questions?

    1-833-389-9450

    Dist. by: RANDOB LABS LTD. Box 440, Cornwall, NY 12518

  • PRINCIPAL DISPLAY PANEL - 113 g Tube Carton

    NEW LOOK-SAME PRODUCT

    Balmex®
    COMPLETE
    PROTECTION™

    Zinc Oxide

    DIAPER RASH CREAM

    Prevents & Heals

    ✔
    Protects against
    all 3 leading causes
    of diaper rash
    ✔
    Reduces rash in
    just 1 diaper change

    Pediatrician Recommended

    Advanced
    Formula

    NET WT 4 OZ (113 g)

    PRINCIPAL DISPLAY PANEL - 113 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    BALMEX DIAPER RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.113 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Dimethicone 100 (UNII: RO266O364U)  
    Soybean Oil (UNII: 241ATL177A)  
    Magnesium Aspartate Anhydrous (UNII: 082H981FMA)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Microcrystalline Wax (UNII: XOF597Q3KY)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Oenothera Biennis (UNII: 76UI55V071)  
    Olea Europaea Leaf (UNII: MJ95C3OH47)  
    Dexpanthenol (UNII: 1O6C93RI7Z)  
    Potassium Aspartate (UNII: OC4598NZEQ)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Sarcosine (UNII: Z711V88R5F)  
    Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
    Tocopherol (UNII: R0ZB2556P8)  
    Water (UNII: 059QF0KO0R)  
    Sodium Cocoyl Glycinate (UNII: XLU9KH03XM)  
    White Wax (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52412-400-041 in 1 CARTON11/01/2018
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:52412-400-16453 g in 1 JAR; Type 0: Not a Combination Product11/01/2018
    3NDC:52412-400-021 in 1 CARTON11/01/2018
    356 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:52412-400-055.1 g in 1 PACKAGE; Type 0: Not a Combination Product11/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34704/27/2015
    Labeler - Randob Labs,Ltd. (061995007)
    Establishment
    NameAddressID/FEIBusiness Operations
    KIK HOLDCO COMPANY INC.243547333MANUFACTURE(52412-400)
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