SOFSKIN BABY- white petrolatum jelly

Sofskin Baby by

Drug Labeling and Warnings

Sofskin Baby by is a Otc medication manufactured, distributed, or labeled by Nova Petroleum & Chemicals Corporation, Kim Chemicals LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

SOFSKIN BABY 
white petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52069-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	225 g  in 225 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52069-103-08	225 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	03/10/2010

Labeler - Nova Petroleum & Chemicals Corporation (831871731)

Establishment
Name	Address	ID/FEI	Business Operations
Kim Chemicals LTD		650470164	MANUFACTURE