Label: 50% ISOPROPYL ALCOHOL- isopropyl alcohol solution
- NDC Code(s): 59640-864-43, 59640-864-45, 59640-864-72
- Packager: H E B
- 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 January 6, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Ask a doctor before use
- When using this product
- Stop use and ask a doctor if
- Keep out of reach of children.
- Caution
- Directions
- Other information
- Inactive ingredient
- SPL UNCLASSIFIED SECTION
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principal display panel
HEB
50% Isopropyl Alcohol
First Aid Antiseptic
- for rubbing and massaging
WARNING FLAMMABLE - Keep away from heat, spark, electrical, fire or flame
Use ony in a well-ventilated area. Fumes can be harmful
CAUTION: Do not point at self or others; product will squirt when squeezed.
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16 FL OZ (1 PT) 473 mL
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INGREDIENTS AND APPEARANCE
50% ISOPROPYL ALCOHOL
isopropyl alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59640-864 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59640-864-72 296 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product 05/01/2018 2 NDC:59640-864-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2018 3 NDC:59640-864-45 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/01/2018 Labeler - H E B (007924756) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(59640-864) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(59640-864)