Label: GUARDEX HAND SANITIZER ANTISEPTIC GEL- isopropyl alcohol 75% gel
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Contains inactivated NDC Code(s)
NDC Code(s): 80307-001-01 - 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 gel
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INGREDIENTS AND APPEARANCE
GUARDEX HAND SANITIZER ANTISEPTIC GEL
isopropyl alcohol 75% gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80307-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL 2839 mL in 3785 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:80307-001-01 3785 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)