Label: BIODCREAM- zinc oxide cream

  • NDC Code(s): 45737-701-04
  • Packager: Advanced Generic Corporation
  • 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 December 23, 2020

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  • Active Ingredient

    Zinc Oxide 15.25%

  • Purpose

    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 avoid contact with eyes.
    • Stop use and ask doctor if condition worsens or lasts more than 7 days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

  • Directions

    • Change wet or soiled diaper promptly
    • Cleanse the diaper area and allow to dry
    • Apply Cream liberally as often as necessary, with each diaper change, especially at bedtime or when exposure to wet diapers may be prolonged.
  • Inactive ingredients

    beeswax, butylated hydroxyl anisole, diazolidinyl urea, lanolin oil, lavender fragrance, methylparaben, paraffinum liquidum, propylene glycol, propylparaben, white petrolatum.

  • Questions or comments:

    1-305-403-3788

  • PRINCIPAL DISPLAY PANEL

    BioDcreamBioDcream

  • INGREDIENTS AND APPEARANCE
    BIODCREAM 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45737-701
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION15.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    LANOLIN OIL (UNII: OVV5IIJ58F)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:45737-701-04125 g in 1 JAR; Type 0: Not a Combination Product04/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34704/01/2016
    Labeler - Advanced Generic Corporation (831762971)
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