ZINC OXIDE CREAM- zinc oxide cream

Zinc Oxide Cream by

Drug Labeling and Warnings

Zinc Oxide Cream by is a Otc medication manufactured, distributed, or labeled by Emerging Pharma, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc Oxide 22%

Purpose

Skin Protectant

Uses

helps treat and prevent diaper rash
protects chafed skin due to diaper rash and helps protect skin from wetness.

Warnings

For external use only

WHEN USING

When using this product do not get into eyes

Stop use and ask a doctor if

conditions worsen
symptoms last more than 7 days or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

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

Other information

store at 20-30°C (68-86°F)

Inactive ingredients

aloe barbadensis leaf juice, caprylyl glycol, ceteareth- 20, cetyl alcohol, chlorphenesin, glycerine, mineral oil, phenoxyethanol, purified water, stearyl alcohol, tocopheryl acetate (vitamin E), white petrolatum

Questions ? 

Call 1-844-221-7294.

SPL UNCLASSIFIED SECTION

Manufactured for 

Emerging Pharmaceuticals
New Jersey, USA

Package Label

NDC 70050-100-04 NET WT: 4 oz (113 grams)

INGREDIENTS AND APPEARANCE

ZINC OXIDE CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70050-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	22 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHLORPHENESIN (UNII: I670DAL4SZ)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WHITE PETROLATUM (UNII: B6E5W8RQJ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70050-100-04	113 g in 1 JAR; Type 0: Not a Combination Product	05/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/01/2022

Labeler - Emerging Pharma, LLC (079862083)