Label: CARS PETROLEUM- white petrolatum jelly
- NDC Code(s): 78495-003-01, 78495-003-02, 78495-003-03, 78495-003-04
- Packager: Ultra Distributors Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated December 2, 2020
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- ASK DOCTOR
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CARS PETROLEUM
white petrolatum jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:78495-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 100 g in 100 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 12/01/2020 Labeler - Ultra Distributors Inc. (007160073) Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(78495-003)
