Label: ADVANCED ALCOHOL GEL SANITIZER- alcohol gel
- NDC Code(s): 65601-796-19, 65601-796-29, 65601-796-57
- Packager: Betco Corporation, Ltd
- 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 August 1, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredient
- Uses
- Purpose
-
Warnings
Warnings
• For external use only.
• Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• FLAMMABLE. This product contains ethyl alcohol. Keep away from
sources of ignition.
• Discontinue use if irritation or redness develops.
• If irritation persists for more than 72 hours, consult a physician.
• KEEP OUT OF REACH OF CHILDREN.
• If swallowed, get medical help or contact a Poison Control Center right away.
- Directions
- Inactive Ingredients
- Warnings
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
ADVANCED ALCOHOL GEL SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65601-796 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 1 mL in 0.7 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) DIMETHICONE PEG-8 LAURATE (UNII: 72MF9C2A18) GLYCERIN (UNII: PDC6A3C0OX) EDETOL (UNII: Q4R969U9FR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65601-796-19 900 mL in 1 BAG; Type 1: Convenience Kit of Co-Package 08/01/2019 2 NDC:65601-796-29 1000 mL in 1 BAG; Type 0: Not a Combination Product 08/01/2019 3 NDC:65601-796-57 550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 08/01/2019 Labeler - Betco Corporation, Ltd (024492831) Registrant - Betco Corporation, Ltd (024492831) Establishment Name Address ID/FEI Business Operations Betco Corporation, Ltd 024492831 manufacture(65601-796) , label(65601-796)
