Label: 50% RUBBING- isopropyl alcohol liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 11344-003-43, 11344-003-45 - Packager: Sound Body
- 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 May 19, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- Warnings
- Flammable
- Ask a doctor before use
- When using this product
- Stop use and ask a doctor
- keep out of children
- Caution
- Directions
- Other Information
- Inactive ingredient
- Adverse reactions
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principal display panel
SOUND
BODY
FIRST AID
ANTISPETIC
50%
Isopropyl
Alcohol
First Aid Antispetic
WARNING FLAMMABLE - Keep away from heat, spark, electrical, fire or flame
Use only in a well-ventilated area; fumes can be harmful
CAUTION: Do not point at self or others; product will squirt when squeezed.
32 FL OZ (1 QT) 946 mL
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INGREDIENTS AND APPEARANCE
50% RUBBING
isopropyl alcohol liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11344-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 500 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11344-003-43 473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/08/2014 2 NDC:11344-003-45 946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/08/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/08/2014 Labeler - Sound Body (150931459) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(11344-003)