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
- Purpose
- USES
- WARNINGS
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
-
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
BURTS BEES BABY BEE DIAPER RASH
zinc oxide ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:26052-028 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 40 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:26052-028-01 85 g in 1 TUBE; Type 0: Not a Combination Product 05/29/2015 2 NDC:26052-028-02 1 in 1 CARTON 05/29/2015 2 85 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 05/29/2015 Labeler - BURT'S BEES, INC. (613480946)