CARS PETROLEUM- white petrolatum jelly
Ultra Distributors 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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Cars Petroleum Jelly

Active Ingredient

White petrolatum USP (100%)

Purpose

Skin protectant

Uses

helps protect chapped skin

Warnings

For external use only

When using this product

do not get into eyes

See a doctor if condition lasts more than 7 days.

Do not use on

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 ingredients

None

PRINCIPAL DISPLAY PANEL

CARS PETROLEUM JELLY

NET WT 6 OZ (170 gm)

label

CARS PETROLEUM
white petrolatum jelly

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78495-003
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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78495-003-01	113 g in 1 JAR; Type 0: Not a Combination Product	12/01/2020
2	NDC:78495-003-02	170 g in 1 JAR; Type 0: Not a Combination Product	12/01/2020
3	NDC:78495-003-03	226 g in 1 JAR; Type 0: Not a Combination Product	12/01/2020
4	NDC:78495-003-04	368 g in 1 JAR; Type 0: Not a Combination Product	12/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	12/01/2020

Labeler - Ultra Distributors Inc. (007160073)

Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211)

Name	Address	ID/FEI	Business Operations
Establishment
Jell Pharmaceuticals Pvt. Ltd.		726025211	manufacture(78495-003)