Label: ADVANCED PETROLATUM- petrolatum ointment
- NDC Code(s): 42213-042-05, 42213-042-28, 42213-042-80
- Packager: Ultra Seal Corporation
- 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 November 14, 2018
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ADVANCED PETROLATUM
petrolatum ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42213-042 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 MINERAL OIL (UNII: T5L8T28FGP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42213-042-80 144 in 1 BOX 04/05/2011 1 NDC:42213-042-05 5 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:42213-042-28 28 g in 1 TUBE; Type 0: Not a Combination Product 04/05/2011 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 04/05/2011 Labeler - Ultra Seal Corporation (085752004) Registrant - Ultra Seal Corporation (085752004) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 pack(42213-042) Establishment Name Address ID/FEI Business Operations Avatar Corporation 103338687 manufacture(42213-042) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 944090448 pack(42213-042)