Label: SKIN PROTECTANT PETROLATUM- petrolatum ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 69375-004-54 - Packager: Nationwide Pharmaceutical, 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 February 23, 2021
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
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- PRINCIPAL DISPLAY PANEL - 454 GM Jar Label
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INGREDIENTS AND APPEARANCE
SKIN PROTECTANT PETROLATUM
petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69375-004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum 44.28 g in 100 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) MICROCRYSTALLINE WAX (UNII: XOF597Q3KY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) POLYSORBATE 60 (UNII: CAL22UVI4M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69375-004-54 454 g in 1 JAR; Type 0: Not a Combination Product 03/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part347 03/01/2021 Labeler - Nationwide Pharmaceutical, LLC (079265801)