FDA.reportPublic FDA data

Sofskin Baby

Manufacturer
Nova Petroleum & Chemicals Corporation | Kim Chemicals LTD
Effective date
2010-03-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:54:19

Label at a glance#

ProductSofskin Baby
Active ingredientPETROLATUM
Label structure7 sections

Indications and uses

helps treat and prevent diaper rash. Help seal out wetness

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Label for

NOVA PETROLEUM & CHEMICALS CORP.

Sofskin Baby Petroleum Jelly

Drug Facts:

Active Ingredients:  

DESCRIPTION SECTION

White Petroleum (USP) 100%

Fragrance, Q.S.

Purpose:

DESCRIPTION SECTION

Skin protectant

USES:

INDICATIONS & USAGE SECTION

helps treat and prevent diaper rash. Help seal out wetness

WARNING:

WARNINGS SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52069-103-082024-11-29C16284748780-1956f9ecf-d9e3-621f-e053-dbdaa90a74adBaby Petroleum Jelly
52069-103-082019-10-21C16284748780-1956f9ecf-d9e3-621f-e053-dbdaa90a74adBaby Petroleum Jelly

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
PETROLATUMACTIVE MOIETY4T6H12BN9U1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52069-10352069-103-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
281677e1-efc5-209f-e063-6394a90ac5cbc07b4566-ffba-4930-81d0-773d13d5dd802024-11-29WarningsExact identifier
spl set id: c07b4566-ffba-4930-81d0-773d13d5dd80

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.