Label: BADGER DIAPER- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 February 18, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    USP Zinc Oxide 10%

  • Purpose

    Skin Protectant

  • Uses

    • Treats and prevents diaper rash
    • Soothes irritated skin
    • Protects against moisture
  • Warnings

    For external use only

    When using this product

    Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    Rash or irritation develops and lasts. Condition persists for more than 7 days.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • Directions

    • Cleanse area, pat dry, then apply an even layer of cream
    • Use every day or if rash is present
  • Ingredients

    1Helianthus Annuus ( Sunflower) Oil, 1Cera Alba ( Beeswax), 1Calendula Officinalis ( Calendula) CO 2 Extract, Tocopherol ( Sunflower Vitamin E).

    1
    = Certified Organic
  • PRINCIPAL DISPLAY PANEL - 87 ml Tube Label

    Label

    BADGER ®

    Calendula

    with Beeswax & Sunflower

    ZINC OXIDE

    DIAPER CREAM


    99% ORGANIC INGREDIENTS

    NSF

    contains organic

    ingredients

    87ml/2.9 fl.oz

  • INGREDIENTS AND APPEARANCE
    BADGER DIAPER 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62206-2850
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62206-2850-187 mL in 1 TUBE; Type 0: Not a Combination Product11/02/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/02/2015
    Labeler - W.S. Badger Company, Inc. (963242326)
    Establishment
    NameAddressID/FEIBusiness Operations
    W.S. BADGER COMPANY, INC.963242326manufacture(62206-2850)
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