Label: BALMEX DIAPER RASH- zinc oxide 11.3% cream

  • NDC Code(s): 52412-285-02, 52412-285-03, 52412-285-04, 52412-285-12, view more
    52412-285-16
  • Packager: Randob Labs, LTD
  • Category: HUMAN OTC DRUG LABEL

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 April 4, 2023

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  • ACTIVE INGREDIENT

    Zinc Oxide 11.3%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    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, seek medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Change wet and 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 anytime when exposure to wet diapers may be prolonged.

  • INACTIVE INGREDIENT

    Beeswax, benzoic acid, dimethicone, glycine soja (soybean) oil, magnesium aspartate, microcrystalline wax, mineral oil, oenothera biennis (evening primrose) seed extract, olea europae (olive) leaf extract, panthenol, Peruvian balsam, Phenoxyethanol, potassium aspartate, potassium hydroxide, sarcosine, sodium cocoyl amino acids, sorbitan sesquioleate, synthetic beeswax, tocopherol, water.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    BALMEX DIAPER RASH 
    zinc oxide 11.3% cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52412-285
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE11.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    DIMETHICONE 350 (UNII: 2Y53S6ATLU)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    EVENING PRIMROSE OIL (UNII: 3Q9L08K71N)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    BALSAM PERU (UNII: 8P5F881OCY)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM ASPARTATE (UNII: OC4598NZEQ)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    SARCOSINE (UNII: Z711V88R5F)  
    COCO ACID CHLORIDES (UNII: R7N8Y0XMX7)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    WATER (UNII: 059QF0KO0R)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52412-285-16453 g in 1 JAR; Type 0: Not a Combination Product04/19/2021
    2NDC:52412-285-12340 g in 1 JAR; Type 0: Not a Combination Product04/19/2021
    3NDC:52412-285-041 in 1 CARTON04/19/2021
    3113 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:52412-285-021 in 1 CARTON04/19/2021
    456 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:52412-285-031 in 1 CARTON04/04/2023
    585 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01604/19/2021
    Labeler - Randob Labs, LTD (061995007)
    Registrant - Derma Care Research Labs (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs116817470manufacture(52412-285)
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