SOFSKIN BABY- white petrolatum jelly 
Nova Petroleum & Chemicals Corporation

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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Baby Petroleum Jelly

Label for

NOVA PETROLEUM & CHEMICALS CORP.

Sofskin Baby Petroleum Jelly

Drug Facts:

Active Ingredients:  

White Petroleum (USP) 100%

Fragrance, Q.S.

Purpose:

Skin protectant

USES:

helps treat and prevent diaper rash. Help seal out wetness

WARNING:

For external use only.

Do not apply over deep puncture wounds.

Infections or lacerations. If redness or swelling develops consult a physician promptly. Keep out of reach of children. If swallowed get medical help or contact Poison control center right away.

DIRECTION:

Apply liberally to clean, dry diaper area

            Made in India

Imported by:

      Nova Petroleum & Chemicals Corp.

      3 Roethal Drive Suite 1 D

      Hopewell Junction, NY 12533

      www.novawax.com

Distributed by:

      Vini Health and Beauty Products Inc.

      3 Roethal Drive Suite 1 D

      Hopewell Junction, NY 12533

Principal Display Panel

Sofskin 
Baby
Jelly
Net Wt. 225g (8 Oz)

Principal Display Panel Sofskin Baby Jelly Net Wt. 225g (8 Oz)

SOFSKIN BABY 
white petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52069-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM225 g  in 225 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52069-103-08225 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34703/10/2010
Labeler - Nova Petroleum & Chemicals Corporation (831871731)
Establishment
NameAddressID/FEIBusiness Operations
Kim Chemicals LTD650470164MANUFACTURE

Revised: 3/2010
Document Id: d76fa296-06de-496f-97e1-d8d59bb45975
Set id: c07b4566-ffba-4930-81d0-773d13d5dd80
Version: 1
Effective Time: 20100308
 
Nova Petroleum & Chemicals Corporation