Label: UNIVERSAL PURE PETROLEUM COCOA BUTTER SCENTED- white petroleum jelly
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NDC Code(s):
52000-007-19,
52000-007-20,
52000-007-21,
52000-007-22, view more52000-007-23, 52000-007-24, 52000-007-25, 52000-007-26, 52000-007-27, 52000-007-28
- 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 October 27, 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 PURE PETROLEUM COCOA BUTTER SCENTED
white petroleum jellyProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52000-007 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 1 g in 1 g Inactive Ingredients Ingredient Name Strength .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.0001 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52000-007-19 226 g in 1 JAR; Type 0: Not a Combination Product 03/01/2020 2 NDC:52000-007-20 45 g in 1 JAR; Type 0: Not a Combination Product 03/01/2020 3 NDC:52000-007-21 100 g in 1 JAR; Type 0: Not a Combination Product 03/01/2020 4 NDC:52000-007-22 113 g in 1 JAR; Type 0: Not a Combination Product 03/01/2020 5 NDC:52000-007-23 170 g in 1 JAR; Type 0: Not a Combination Product 03/01/2020 6 NDC:52000-007-24 198 g in 1 JAR; Type 0: Not a Combination Product 03/01/2020 7 NDC:52000-007-25 283 g in 1 JAR; Type 0: Not a Combination Product 03/01/2020 8 NDC:52000-007-26 368 g in 1 JAR; Type 0: Not a Combination Product 03/01/2020 9 NDC:52000-007-27 450 g in 1 JAR; Type 0: Not a Combination Product 03/01/2020 10 NDC:52000-007-28 500 g in 1 JAR; Type 0: Not a Combination Product 03/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/06/2013 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(52000-007)