Label: BALMEX ADULT CARE RASH- zinc oxide cream

  • NDC Code(s): 52412-500-03, 52412-500-12
  • 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

  • SPL UNCLASSIFIED SECTION

  • ACTIVE INGREDIENT

    Active Ingredients                                     Purpose
    Zinc Oxide 11.3%Skin protectant
  • Uses

    • helps relieve and prevent rashes and irritation due to wetness from incontinence
    • protects chafed skin due to irritation and helps seal out wetness
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist 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

    • gently cleanse affected skin
    • pat dry with a clean, soft cloth or allow to air dry
    • apply generously to affected area as needed, especially after incontinence episodes
    • using a dry tissue to remove excess product from skin is most effective
  • STORAGE AND HANDLING

  • INACTIVE INGREDIENT

    Inactive ingredients mineral oil, water, beeswax, microcrystalline wax, synthetic beeswax, fragrance, sorbitan sesquioleate, oenothera biennis (evening primrose) seed extract, olea europaea (olive) leaf extract, dimethicone, tocopherol, methylparaben, glycine soja (soybean) oil, propylparaben, panthenol, sarcosine, benzoic acid, potassium aspartate, potassium hydroxide, magnesium aspartate, sodium cocoyl amino acids (309-021) 

  • QUESTIONS

    For more information please visit 
    www.BalmexAdult.com

  • SPL UNCLASSIFIED SECTION

    Distributed by RANDOB LABS LTD.
    Box 440, Cornwall, NY 12518

  • PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

    Activ
    Guard™

    NEUTRALIZES
    IRRITANTS

    Balmex®
    ADULTCARE™

    RASH CREAM
    ZINC OXIDE 11.3%

    Soothes &
    Protects Skin
    From Irritation, Chafing & Rash

    Dermatologist Tested
    Works in One Use*
    Odor-Free

    NET WT 3 OZ (85 g)

    PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    BALMEX ADULT CARE RASH 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-500
    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
    Mineral Oil (UNII: T5L8T28FGP)  
    Water (UNII: 059QF0KO0R)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Microcrystalline Wax (UNII: XOF597Q3KY)  
    Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
    Oenothera Biennis (UNII: 76UI55V071)  
    Olea Europaea Leaf (UNII: MJ95C3OH47)  
    Dimethicone 100 (UNII: RO266O364U)  
    Tocopherol (UNII: R0ZB2556P8)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Soybean Oil (UNII: 241ATL177A)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Dexpanthenol (UNII: 1O6C93RI7Z)  
    Sarcosine (UNII: Z711V88R5F)  
    Benzoic Acid (UNII: 8SKN0B0MIM)  
    Potassium Aspartate (UNII: OC4598NZEQ)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Magnesium Aspartate Anhydrous (UNII: 082H981FMA)  
    Sodium Cocoyl Glycinate (UNII: XLU9KH03XM)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    White Wax (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52412-500-031 in 1 CARTON11/01/2018
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:52412-500-12340 g in 1 JAR; 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(52412-500)
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