Label: WHITE PETROLATUM ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 0168-0053-16, 0168-0053-21, 0168-0053-31, 0168-0053-45 - Packager: E. Fougera & Co. a division of Fougera Pharmaceuticals 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 August 30, 2012
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient:
- Purpose:
- INDICATIONS & USAGE
- WARNINGS
- Keep out of reach of children.
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
- PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
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INGREDIENTS AND APPEARANCE
WHITE PETROLATUM
white petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0168-0053 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 PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0168-0053-16 453.6 g in 1 JAR 2 NDC:0168-0053-21 1 in 1 CARTON 2 28.35 g in 1 TUBE 3 NDC:0168-0053-31 144 in 1 CARTON 3 28.35 g in 1 TUBE 4 NDC:0168-0053-45 1 in 1 CARTON 4 5 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 01/01/1968 Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)