Label: UBREDOL- methyl salicylate ointment
- NDC Code(s): 55758-377-03
- Packager: Pharmadel LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 June 20, 2023
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INGREDIENTS AND APPEARANCE
UBREDOL
methyl salicylate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-377 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 10 g in 100 g Inactive Ingredients Ingredient Name Strength CAMPHOR, (-)- (UNII: 213N3S8275) LEVOMENTHOL (UNII: BZ1R15MTK7) D&C YELLOW NO. 11 (UNII: 44F3HYL954) MINERAL OIL (UNII: T5L8T28FGP) PARAFFIN (UNII: I9O0E3H2ZE) PROPYLPARABEN (UNII: Z8IX2SC1OH) PETROLATUM (UNII: 4T6H12BN9U) LANOLIN OIL (UNII: OVV5IIJ58F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-377-03 85 g in 1 JAR; Type 0: Not a Combination Product 06/20/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 06/20/2023 Labeler - Pharmadel LLC (030129680)