White Rain Cocoa Butter Petroleum Jelly

white rain Cocoa Butter Petroleum Jelly by

Drug Labeling and Warnings

white rain Cocoa Butter Petroleum Jelly by is a Otc medication manufactured, distributed, or labeled by INTERNATIONAL WHOLESALE INC., Jell Pharmaceuticals Pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

WHITE RAIN COCOA BUTTER PETROLEUM JELLY- white petrolatum jelly 
INTERNATIONAL WHOLESALE INC.

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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White Rain 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

WHITE RAIN COCOA BUTTER PETROLEUM JELLY 
white petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52862-132
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	0.1 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52862-132-01	170 g in 1 JAR; Type 0: Not a Combination Product	01/15/2022
2	NDC: 52862-132-02	113 g in 1 JAR; Type 0: Not a Combination Product	01/15/2022
3	NDC: 52862-132-03	50 g in 1 JAR; Type 0: Not a Combination Product	01/15/2022
4	NDC: 52862-132-04	100 g in 1 JAR; Type 0: Not a Combination Product	01/15/2022
5	NDC: 52862-132-05	226 g in 1 JAR; Type 0: Not a Combination Product	01/15/2022
6	NDC: 52862-132-06	283 g in 1 JAR; Type 0: Not a Combination Product	01/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/08/2022	02/02/2022

Labeler - INTERNATIONAL WHOLESALE INC. (161872676)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Establishment
Name	Address	ID/FEI	Business Operations
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(52862-132)

Revised: 2/2022

Document Id: d702cddd-6809-b338-e053-2995a90a4e28

34390-5

Set id: d6ec0e28-aa21-2008-e053-2995a90ac028

Version: 2

Effective Time: 20220201