Label: UNIVERSAL BABY FRESH SCENT PETROLEUM- white petroleum jelly
- NDC Code(s): 52000-118-01, 52000-118-02, 52000-118-03, 52000-118-04
- Packager: Universal Distribution Center LLC
- 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 November 1, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
UNIVERSAL BABY FRESH SCENT PETROLEUM
white petroleum jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-118 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 99.9 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-118-01 170 g in 1 JAR; Type 0: Not a Combination Product 11/01/2019 2 NDC:52000-118-02 226 g in 1 JAR; Type 0: Not a Combination Product 11/01/2019 3 NDC:52000-118-03 368 g in 1 JAR; Type 0: Not a Combination Product 11/01/2019 4 NDC:52000-118-04 510 g in 1 JAR; Type 0: Not a Combination Product 11/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 11/01/2019 Labeler - Universal Distribution Center LLC (019180459) Registrant - Jell Pharmaceuticals Pvt Ltd. (726025211) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt Ltd 726025211 manufacture(52000-118)