Label: BADGER ESSENTIAL BABY SET- zinc oxide kit

  • 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 December 19, 2022

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  • Active Ingredient

    Zinc oxide 10%

    Purpose

    Skin Protectant

    Keep out of reach of children

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

  • Uses

    ■ Treats and prevents diaper rash ■ Soothes irritated skin ■ Protects against moisture

    Directions

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

  • INACTIVE INGREDIENT

    *Helianthus Annuus (Sunflower) Seed Oil, *Cera Alba (Beeswax), *Calendula Officinalis (Calendula) Flower Extract, Tocopherol (Sunflower Vitamin E). * = Certified Organic

  • Warnings

    For external use only

    When using this product

    When using this product: Keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    Stop use and ask a doctor if: Rash or irritation develops and lasts. Condition persists for more than 7 days.

  • PRINCIPAL DISPLAY PANEL

    Diaper Cream

    Keeps skin soft and dry. Zinc Oxide treats and prevents diaper rash.

    Carton

  • INGREDIENTS AND APPEARANCE
    BADGER ESSENTIAL BABY SET 
    zinc oxide kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62206-3360
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62206-3360-11 in 1 KIT; Type 0: Not a Combination Product06/21/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 87 mL
    Part 21 CAN 21 g
    Part 31 BOTTLE 118 mL
    Part 1 of 3
    BADGER DIAPER 
    zinc oxide cream
    Product Information
    Item 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)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62206-2850-187 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/02/2015
    Part 2 of 3
    BABY BALM  BADGER
    lotions, oils, powders, and creams cream
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGROLIVE OIL (UNII: 6UYK2W1W1E)  
    INGRYELLOW WAX (UNII: 2ZA36H0S2V)  
    INGRCASTOR OIL (UNII: D5340Y2I9G)  
    INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    INGRCHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    121 g in 1 CAN; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/21/2017
    Part 3 of 3
    BABY OIL  BADGER
    lotions, oils, powders, and creams oil
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGROLIVE OIL (UNII: 6UYK2W1W1E)  
    INGRJOJOBA OIL (UNII: 724GKU717M)  
    INGRCALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    INGRCHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/21/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/21/2017
    Labeler - W.S. Badger Company, Inc. (963242326)
    Establishment
    NameAddressID/FEIBusiness Operations
    W.S. Badger Company, Inc.963242326manufacture(62206-3360)