LIVE CLEAN BABY- zinc oxide cream

LIVE CLEAN BABY by

Drug Labeling and Warnings

LIVE CLEAN BABY by is a Otc medication manufactured, distributed, or labeled by BELVEDERE INTERNATIONAL INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

DRUG FACTS

HELPS TREAT AND PREVENT DIAPER RASH

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMIDIATELY.

INDICATIONS & USAGE

HELPS TREAT AND PREVEND DIAPER RASH

PROTECTS CHAFED SKIN DUE TO DIAPER RASH

HELPS SEAL OUT WETNESS

WARNINGS

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT AVOID CONTACT WITH EYES.

STOP USE AND ASK A DOCTOR IF CONDITION WORSENS OR DOES NOT IMPROVE WITHIN 7 DAYS.

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMIDIATELY.

DOSAGE & ADMINISTRATION

■ Change wet and soiled diapers promptly. Cleanse the diaper area, and allow to dry. ■ Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged.

INACTIVE INGREDIENT

Ricinus Communis (Castor) Seed Oil, Cera Alba (beeswax), Simmondsia Chinensis (Jojoba) Seed Oil, Tocopheryl Acetate, Lavandula Hybrida Oil, Lavandula Angustifolia (Lavender) Extract*, Chamomilla Recutita (Matricaria) Flower Extract*, Aloe Barbadensis Leaf Extract*

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LIVE CLEAN BABY 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60742-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
JOJOBA OIL (UNII: 724GKU717M)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
LAVENDER OIL (UNII: ZBP1YXW0H8)
LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)
CHAMOMILE (UNII: FGL3685T2X)
ALOE (UNII: V5VD430YW9)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60742-003-01	75 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	01/01/2015

Labeler - BELVEDERE INTERNATIONAL INC. (247836356)

Registrant - BELVEDERE INTERNATIONAL INC. (247836356)

Establishment
Name	Address	ID/FEI	Business Operations
BELVEDERE INTERNATIONAL INC.		247836356	manufacture(60742-003)