Label: BURTS BEES BABY BEE DIAPER RASH- zinc oxide ointment

  • NDC Code(s): 26052-028-01, 26052-028-02
  • Packager: BURT'S BEES, INC.
  • 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 21, 2018

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  • ACTIVE INGREDIENT

    Zinc Oxide 40%

  • 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 keep out of eyes.

  • STOP USE

    Stop use and ask a doctor if condition worstened or does not improve after 7 days

  • KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    • CHANGE WET AND SOILED DIAPERS PROMPTLY.
    • CLEANSE THE DIAPER AREA AND ALLOW TO DRY.
    • APPLY OINTMENT LIBERALLY, AS OFTEN AS NECESSARY, WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE PROLONGED.
  • INACTIVE INGREDIENTS

    PRUNUS AMYGDALUS DULCIS (SWEET ALMOND) OIL, BEESWAX, LANOLIN, RICINUS COMMUNIS (CASTOR) SEED OIL, SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, GLYCERYL ROSINATE, OLEA EUROPAEA (OLIVE) FRUIT OIL, HYDROGENATED CASTOR OIL, OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES, ANTHEMIS NOBILIS FLOWER OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER, LAVANDULA HYBRIDA OIL, CALENDULA OFFICINALIS FLOWER EXTRACT, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, TOCOPHEROL, GLYCINE SOJA (SOYBEAN) OIL, CANOLA OIL

  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE

  • PRINCIPAL DISPLAY PANEL

    MAXIMUM STRENGTH - 40% ZINC OXIDE

    BURT'S BEES

    BABY BEE

    DIAPER RASH OINTMENT

    HELPS TREAT & PREVENT DIAPER RASH

    100% NATURAL

    NET WT. 3 oz. / 85 g

    Baby Bee Diaper Ointment

  • INGREDIENTS AND APPEARANCE
    BURTS BEES BABY BEE DIAPER RASH 
    zinc oxide ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:26052-028
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE40 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SHEA BUTTER (UNII: K49155WL9Y)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    JOJOBA OIL (UNII: 724GKU717M)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    CHAMAEMELUM NOBILE FLOWER OIL (UNII: UB27587839)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    ROSEMARY (UNII: IJ67X351P9)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:26052-028-0185 g in 1 TUBE; Type 0: Not a Combination Product05/29/2015
    2NDC:26052-028-021 in 1 CARTON05/29/2015
    285 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/29/2015
    Labeler - BURT'S BEES, INC. (613480946)
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