BABY DIAPER- zinc oxide cream

BABY DIAPER by

Drug Labeling and Warnings

BABY DIAPER by is a Otc medication manufactured, distributed, or labeled by TELLURIAN. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS

ZINC OXIDE, 10%

PURPOSE

PURPOSE

SKIN PROTECTANT

INDICATIONS & USAGE

USE

• HELPS TREAT AND PREVENT DIAPER RASH.
• PROTECTS CHAPPED SKIN DUE TO DIAPER RASH AND HELPS PROTECT FROM WETNESS.

WARNINGS

WARNINGS

FOR EXTERNAL USE ONLY

WHEN USING

WHEN USING THIS PRODUCT DO NOT GET INTO EYES.

STOP USE

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

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED, SEEK MEDICAL HELP OR CALL POISON CONTROL CENTER IMMEDIATELY.

DOSAGE & ADMINISTRATION

DIRECTIONS

• CHANGE WET AND SOILED DIAPER IMMEDIATELY
• CLEANSE THE DIAPER AREA AND ALLOW SKIN TO DRY.
• APPLY OINTMENT LIBERALLY AND AS OFTEN AS NECESSARY WITH EACH DIAPER CHANGE, ESPECIALLY WHEN EXPOSED TO WET DIAPERS FOR A PROLONGED PERIOD OF TIME, SUCH AS BEDTIME.

INACTIVE INGREDIENT

Inactive Ingredients: Water, Ethylhexyl Palmitate, Ricinus Communis (Castor) Seed Oil, Polyglycerin-6 Polyricinoleate, Polyglyceryl-10 Hexaoleate, Glycerin, Dimethicone, Sodium PCA, Ceramide 2, Ceramide 3, Ceramide 6lf, Aloe Barbadensis Leaf Juice, Hyaluronic Acid, Macadamia Ternifolia Seed Oil, Vegetable Oil, Camellia Saliva Seed Oil, Phytostearyl Canola Glycerides, Chamomilla Recutita (Matricaria) Extract, Panthenol (Vitamin B5), Tocopheryl Linoleate, Hydrogenated Coco-Glycerides, Myristyl Myristate, Sorbitan Laurate, Sodium Chloride, Zinc Sulfate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Sodium Benzoate, Potassium Sorbate.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY DIAPER 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42643-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	10 g  in 10 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
CASTOR OIL (UNII: D5340Y2I9G)
POLYGLYCERIN-6 (UNII: M51422LRAM)
POLYGLYCERYL-10 HEXAOLEATE (UNII: 8S25IPV09I)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
CERAMIDE 3 (UNII: 4370DF050B)
CERAMIDE 6 II (UNII: F1X8L2B00J)
CERAMIDE 2 (UNII: C04977SRJ5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
HYALURONIC ACID (UNII: S270N0TRQY)
MACADAMIA OIL (UNII: 515610SU8C)
CORN OIL (UNII: 8470G57WFM)
CANOLA OIL (UNII: 331KBJ17RK)
MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Coco-Glycerides (UNII: ISE9I7DNUG)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
SORBITAN MONOLAURATE (UNII: 6W9PS8B71J)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC SULFATE ANHYDROUS (UNII: 0J6Z13X3WO)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42643-101-14	100 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2013

Labeler - TELLURIAN (054233646)