DIAPER RASH CREAM HAPPY CHEEKS- diaper rash happy cheeks cream

Diaper Rash Cream Happy Cheeks by

Drug Labeling and Warnings

Diaper Rash Cream Happy Cheeks by is a Otc medication manufactured, distributed, or labeled by Dimples Bath Co. LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Zinc Oxide 14.9%

PURPOSE

Skin Protectorant

Uses

Helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash. Helps seal out wetness

WARNINGS

For external use only

When using this product do not get into eyes

Stop use and ask a doctor if

Condition worsens Symptoms last more than 7 days or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

If swallowed, get medical help or contact a Poison Control Center immediately

DOSAGE & ADMINISTRATION

Change wet and soild diapers promptly, cleanse the diaper area, and allow to dry. Shake well before use. Spray 4-6 inches away from the skin. Spray product liberally as often as needed, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. No need to rub in

INACTIVE INGREDIENT

Aloe Barbadensis Leaf Juice, Bentonite, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Coco Glucoside, Glycerin, Glyceryl Oleate, Glyceryl Rosinate, Microcrystalline Cellulose, Olea Europaea (Olive) Fruit Oil, Olea Europaea (Olive) Oil Unsaponifiables, Propanediol, Ricinus Communis (Castor) Seed Oil, Water

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun May stain some fabrics and surfaces

QUESTIONS

212-627-0377 M-F 9am to 5pm EST

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIAPER RASH CREAM HAPPY CHEEKS 
diaper rash happy cheeks cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84568-549
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERYL OLEATE (UNII: 4PC054V79P)
WATER (UNII: 059QF0KO0R)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
GLYCERIN (UNII: PDC6A3C0OX)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
OLEA EUROPAEA (OLIVE) FRUIT OIL (UNII: 6UYK2W1W1E)
CELLULOSE GUM (UNII: K679OBS311)
CETEARYL ALCOHOL (UNII: 2DMT128M1S)
RICINUS COMMUNIS (CASTOR) SEED OIL (UNII: D5340Y2I9G)
PROPANEDIOL (UNII: 5965N8W85T)
BENTONITE (UNII: A3N5ZCN45C)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
COCO-GLUCOSIDE (UNII: ICS790225B)
GLYCERYL ROSINATE (UNII: SD112V492J)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84568-549-15	89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	11/13/2024

Labeler - Dimples Bath Co. LLC (119296438)