PETROLEUM- white petrolatum jelly
QUALITY CHOICE (Chain Drug Marketing Association)

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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Quality Choice Petrolatum Jelly

Warning

For External Use Only

Active Ingredient

Name Purpose

White Petrolatum 100% USP .............................. Skin Protectant

Inactive Ingredsient

Water

Purpose

Skin Protectant

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222)right away

Uses

Temporarily Protects:

minor cuts, scrapes, burns and helps relieve chapped or cracked skin and lips from the drying effects of wind and cold weather

Dosage

Applied as needed.

Label

NDC:63868-601-13

Label Image

PETROLEUM
white petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-601
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-601-13	368 g in 1 JAR; Type 0: Not a Combination Product	01/01/2020
2	NDC:63868-601-04	113 g in 1 JAR; Type 0: Not a Combination Product	01/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/01/2020

Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Name	Address	ID/FEI	Business Operations
Establishment
Jell Pharmaceuticals Private Limited		726025211	manufacture(63868-601)