ZINC OXIDE CREAM- zinc oxide cream 
Emerging Pharma, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Zinc Oxide Cream

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 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. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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.

Manufactured for 

Emerging Pharmaceuticals
New Jersey, USA

Package Label

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

image description

ZINC OXIDE CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70050-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE22 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70050-100-04113 g in 1 JAR; Type 0: Not a Combination Product05/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/01/2022
Labeler - Emerging Pharma, LLC (079862083)

Revised: 5/2022
Document Id: 854c3e8a-b7db-4a06-9196-19390fd9ff73
Set id: 70f85a4a-d4d6-4863-bdb3-2ef8d85986e7
Version: 1
Effective Time: 20220501
 
Emerging Pharma, LLC