COCOA BUTTER PETROLEUM JELLY- white petrolatum jelly
Jell Pharmaceuticals Pvt. 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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Cocoa Butter Petroleum Jelly

Active Ingredient

White Petrolatum USP (99%)

Purpose

Skin protectant

Uses

• For the temporary protection of minor cuts, scrapes, burns
• Helps to temporarily protect chafed, chapped, cracked or windburned skin and lips.

Warnings

For External Use Only

Do not use on deep puncture wounds, animal bites, or serious burns. Ask a doctor.

When using this product avoid contact with eyes.

Stop use and ask doctor if condition worsens or does not improve within 7 days.

Keep out of reach of children if swallowed get medical help or contact a Poison Control Center right away.

Directions

apply product liberally, as often as necessary.

Inactive ingredients

Theobroma Cacao (Cocoa) Seed Butter, fragrance

Label

COCOA BUTTER PETROLEUM JELLY
white petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:30400-503
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	99 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
COCOA BUTTER (UNII: 512OYT1CRR)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:30400-503-01	49 g in 1 JAR; Type 0: Not a Combination Product	12/24/2020
2	NDC:30400-503-02	100 g in 1 JAR; Type 0: Not a Combination Product	12/24/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	12/24/2020

Labeler - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Name	Address	ID/FEI	Business Operations
Establishment
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(30400-503)