BURTS BEES BABY BEE DIAPER RASH- zinc oxide ointment

BURTS BEES BABY BEE DIAPER RASH by

Drug Labeling and Warnings

BURTS BEES BABY BEE DIAPER RASH by is a Otc medication manufactured, distributed, or labeled by BURT'S BEES, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BURTS BEES BABY BEE DIAPER RASH 
zinc oxide ointment

Product 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)