Label: WHITE PETROLATUM- petrolatum ointment
- NDC Code(s): 58980-350-50
- Packager: STRATUS PHARMACEUTICALS INC
- Category: HUMAN OTC DRUG LABEL
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 4, 2022
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Indications
- Warnings
- Directions
- Other Information
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Description
White Petrolatum USP is a first aid ointment that protects and revitalizes chapped and cracked skin areas. It contains 100% White Petrolatum USP to help seal moisture into the skin. White Petrolatum USP Ointment can be applied to minor skin injuries including cuts, scrapes, rashes and burns. Each pouch contains a 5g unit dose individually sealed and barcoded.
- SPL UNCLASSIFIED SECTION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - 5 g Packet Box
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INGREDIENTS AND APPEARANCE
WHITE PETROLATUM
petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-350 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM 5 [USP'U] in 5 g Product Characteristics Color WHITE (OFF WHITE) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58980-350-50 144 in 1 BOX 07/12/2019 1 5 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 07/12/2019 Labeler - STRATUS PHARMACEUTICALS INC (789001641) Establishment Name Address ID/FEI Business Operations TARMAC PRODUCTS INC 059890491 MANUFACTURE(58980-350)