ATOPALM DIAPER RASH - zinc oxide cream 
NeoPharm Co., Ltd

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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ATOPALM Diaper Rash Cream

ATOPALM Diaper Rash Cream


Active Ingredient

Zinc Oxide 10%

Purpose

Skin Protectant

Uses

Warnings

For external use only.

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

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

Directions

Other Information

Questions or information call toll free:

1-855-ATOPALM

Inactive Ingredients

WATER, WHITE PETROLATUM, LIGHT MINERAL OIL, SORBITAN SESQUILEATE, WHITE BEESWAX, TALC, STEARIC ACID, DIMETHICONE, ALOE VERA GEL, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA, CHOLESTEROL, PANTHENOL, TOCOPHERYL ACETATE, BENZYL ALCOHOL, SODIUM BENZOATE, FRAGRANCE.

ATOPALM Diaper Rash Cream 2oz (51141-0237-2)


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InnerPackage

ATOPALM DIAPER RASH 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0237
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
WHITE WAX (UNII: 7G1J5DA97F)  
TALC (UNII: 7SEV7J4R1U)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-0237-257 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34706/07/2012
Labeler - NeoPharm Co., Ltd (965502912)
Registrant - NeoPharm Co., Ltd (965502912)
Establishment
NameAddressID/FEIBusiness Operations
NeoPharm Co., Ltd631101883manufacture

Revised: 6/2012
Document Id: da4fcde6-b7da-4442-ba8e-3793aa624d11
Set id: b48d733f-a918-481a-88b5-eb36319aa7e9
Version: 2
Effective Time: 20120611
 
NeoPharm Co., Ltd