Drug Facts

Active Ingredients

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,

do not get into eyes

Stop use and ask a doctor

if condition worsens or 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 right away

Directions

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, and especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

Do not use if quality seal is broken
Do not store above 40C (104F)

Inactive Ingredients

Helianthus Annus (Sunflower) Seed Oil*, Ricinus Communis (Castor) Seed Oil*, Butyrospermum Parkii (Shea) Butter*, Polyhydroxystearic Acid, Helianthus Anuus (Sunflower) Seed Wax*, Cocos Nucifera (Coconut) Oil*, Theobroma Cacao (Cocoa) Seed Butter*, Colophyllum Tacamahaca Seed Oil*, Tocopherol*, Zea Mays (Corn) Starch*

*Organic

HelloBello-dieline-DiaperRashCream-4oz-box-Jan2023_AO

DIAPER RASH CREAM
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73418-300
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	400 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
STARCH, CORN (UNII: O8232NY3SJ)
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)
CASTOR OIL (UNII: D5340Y2I9G)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)
COCOA BUTTER (UNII: 512OYT1CRR)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
COCONUT OIL (UNII: Q9L0O73W7L)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73418-300-08	1 in 1 CARTON	10/13/2023
1	NDC:73418-300-04	113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	10/13/2023

Labeler - Hello Bello (081135707)

Diaper Rash Cream