ZINC OXIDE 40%- diaper rash skin cream

Zinc Oxide 40% by

Drug Labeling and Warnings

Zinc Oxide 40% by is a Otc medication manufactured, distributed, or labeled by BRANDS INTERNATIONAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

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.
• symptoms last more than 7 days or clear up and occur again within a few days

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• change wet and soiled diapers promptly
• cleanse the diaper area
• allow to dry
• apply paste liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

Other Information

• See box for more details

Inactive Ingredients

Sunflower oil, Castor Oil, Sunflower seed wax, polyhydroxystearic acid, shea butter, coconut oil, theobroma cacao seed butter, calophyllum seed oil, tocopherol, zea mays corn starch

Questions and comments?

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Label

INGREDIENTS AND APPEARANCE

ZINC OXIDE 40% 
diaper rash skin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50157-477
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	40 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
SHEA BUTTER (UNII: K49155WL9Y)
COCOA BUTTER (UNII: 512OYT1CRR)
CALOPHYLLUM TACAMAHACA SEED OIL (UNII: 05G85L61OE)
STARCH, CORN (UNII: O8232NY3SJ)
SUNFLOWER OIL (UNII: 3W1JG795YI)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CASTOR OIL (UNII: D5340Y2I9G)
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50157-477-18	118 mL in 1 TUBE; Type 0: Not a Combination Product	09/20/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M016	09/20/2022

Labeler - BRANDS INTERNATIONAL (243748238)

Establishment
Name	Address	ID/FEI	Business Operations
BRANDS INTERNATIONAL		243748238	manufacture(50157-477)