Label: ADVANCED ALCOHOL GEL SANITIZER- alcohol gel
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NDC Code(s):
65601-801-04,
65601-801-19,
65601-801-29,
65601-801-55, view more65601-801-57, 65601-801-99
- Packager: Betco Corporation, Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated July 3, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- Uses
- Purpose
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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
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INGREDIENTS AND APPEARANCE
ADVANCED ALCOHOL GEL SANITIZER
alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65601-801 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 0.7 mL in 1 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:65601-801-19 900 mL in 1 BAG; Type 1: Convenience Kit of Co-Package 08/01/2019 2 NDC:65601-801-29 1000 mL in 1 BAG; Type 0: Not a Combination Product 08/01/2019 3 NDC:65601-801-57 550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 08/01/2019 4 NDC:65601-801-04 3780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 08/01/2019 5 NDC:65601-801-55 208198 mL in 1 DRUM; Type 0: Not a Combination Product 08/01/2019 6 NDC:65601-801-99 1041000 mL in 1 CONTAINER; Type 0: Not a Combination Product 07/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 08/01/2019 Labeler - Betco Corporation, Ltd (005050158) Registrant - Betco Corporation, Ltd (005050158) Establishment Name Address ID/FEI Business Operations Betco Corporation, Ltd 005050158 manufacture(65601-801) , label(65601-801)