Label: ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN- isopropyl alcohol liquid
- NDC Code(s): 51628-4233-1, 51628-4233-2, 51628-4233-3
- Packager: My Imports USA, 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 February 19, 2022
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- ASK DOCTOR
- DO NOT USE
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- SPL UNCLASSIFIED SECTION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREEN
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51628-4233 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 50 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYL SALICYLATE (UNII: LAV5U5022Y) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 5 (UNII: I753WB2F1M) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51628-4233-1 355 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/18/2020 2 NDC:51628-4233-2 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/18/2020 3 NDC:51628-4233-3 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/18/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 06/18/2020 Labeler - My Imports USA, LLC (195767988) Registrant - Jell Pharmaceuticals Pvt. Ltd. (726025211) Establishment Name Address ID/FEI Business Operations Jell Pharmaceuticals Pvt. Ltd. 726025211 manufacture(51628-4233)