PETROLEUM JELLY COCOA BUTTER SCENT 3.53OZ- petrolatum ointment

Petroleum Jelly Cocoa Butter Scent 3.53oz by

Drug Labeling and Warnings

Petroleum Jelly Cocoa Butter Scent 3.53oz by is a Otc medication manufactured, distributed, or labeled by Rejoice International Corp., Gandhar Oil Refinery (India) Ltd., UMENDRA LIFE SCIENCES PRIVATE LIMITED, Astonea Labs Private Limited, VASA Cosmetics Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Petrolatum 99.6%

Purpose

Skin protectant

Use

• helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.

Warnings

For external use only

When using this product

When using this product do not get into eyes.

Stop use and ask a doctor if

• condition worsens
• symtoms last more than 7 days or clear up and occur again within a few days.

Do not use

• deep or puncture wounds
• animal bites
• serious burns

Keep out of reach of children

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

Directions

• apply as needed.

Inactive ingredient

Fragrance

label

INGREDIENTS AND APPEARANCE

PETROLEUM JELLY COCOA BUTTER SCENT 3.53OZ 
petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57337-163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
FRAGRANCE 13576 (UNII: 5EM498GW35)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57337-163-01	100 g in 1 JAR; Type 0: Not a Combination Product	03/06/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	03/06/2024

Labeler - Rejoice International Corp. (078741245)

Establishment
Name	Address	ID/FEI	Business Operations
Gandhar Oil Refinery (India) Ltd.		725188184	manufacture(57337-163)

Establishment
Name	Address	ID/FEI	Business Operations
UMENDRA LIFE SCIENCES PRIVATE LIMITED		767611315	manufacture(57337-163)

Establishment
Name	Address	ID/FEI	Business Operations
Astonea Labs Private Limited		878533295	manufacture(57337-163)

Establishment
Name	Address	ID/FEI	Business Operations
VASA Cosmetics Private Limited		955446947	manufacture(57337-163)