Label: WHITE PETROLATUM ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 54162-597-05, 54162-597-28 - Packager: GERITREX 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 12, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients
- Purpose
- Uses
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Warnings
Stop use and ask a doctor if:
- condition worsens
- symptoms last for more than 7 days or clear up and occur again within a few days
- Directions
- Other information
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
WHITE PETROLATUM
white petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54162-597 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 (UNII: H4N855PNZ1) 0.001 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54162-597-28 28 g in 1 TUBE; Type 0: Not a Combination Product 09/27/2018 2 NDC:54162-597-05 5 g in 1 POUCH; Type 0: Not a Combination Product 07/31/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 07/31/2015 Labeler - GERITREX LLC (112796248) Establishment Name Address ID/FEI Business Operations GERITREX LLC 112796248 manufacture(54162-597)