Label: GUARDEX HAND SANITIZER ANTISEPTIC SOLUTION- isopropyl alcohol 75% liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 80307-002-04, 80307-002-08, 80307-002-16, 80307-002-33 - Packager: Guardex Labs, Inc.
- 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 September 3, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
- Warnings
- Do not use
- When using this product
- Stop use and ask a doctor
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- Guardex Hand Sanitizer Antiseptic Topical Solution
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INGREDIENTS AND APPEARANCE
GUARDEX HAND SANITIZER ANTISEPTIC SOLUTION
isopropyl alcohol 75% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80307-002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 187.5 mL in 250 mL Inactive Ingredients Ingredient Name Strength TRIETHANOLAMINE TRISTEARATE (UNII: HOM72YRP1F) HYDROGEN PEROXIDE (UNII: BBX060AN9V) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) (3-BROMOPROPYL)BENZENE (UNII: 6VX623QN9V) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80307-002-08 250 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 2 NDC:80307-002-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 3 NDC:80307-002-16 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 4 NDC:80307-002-33 1000 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/01/2020 Labeler - Guardex Labs, Inc. (117630183) Registrant - Guardex Labs, Inc. (117630183)