BABY DIAPER RASH CREAM- zinc oxide cream

Baby Diaper Rash Cream by

Drug Labeling and Warnings

Baby Diaper Rash Cream by is a Otc medication manufactured, distributed, or labeled by Hello Bello. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

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

Sunflower Seed Oil, Castor Seed Oil, Cera Alba (Beeswax), Cocos Nucifera Oil, Simmondsia Chinensis (Jojoba) Oil, Shea Butter, Tocopherol, Citric Acid

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

BABY DIAPER RASH CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73418-301
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID (UNII: 2968PHW8QP)
BEESWAX (UNII: 2ZA36H0S2V)
JOJOBA OIL (UNII: 724GKU717M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73418-301-01	1 in 1 CARTON	11/06/2025
1		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 Drug	M016	10/13/2023

Labeler - Hello Bello (081135707)