Label: BEXTERA HEALTH HAND SANITIZER- ethyl alcohol gel
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Contains inactivated NDC Code(s)
NDC Code(s): 77342-101-01 - Packager: Bextera Llc
- Category: HUMAN OTC DRUG LABEL
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 7, 2020
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- Official Label (Printer Friendly)
- Drug Facts
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- STORAGE AND HANDLING
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
ANTIBACTERIAL
ANTIVIRAL
KILLS MOST GERMS
SOURCED FROM A GMP CERTIFIED FACILITY
Manufactured in a FDA registered Facility
MADE IN U.S.A
*These statements have not been evaluated by the Food and Drug Administration.
This product is not intended to diagnose, treat, cure, or prevent any disease.
Distributed by: Bextra Nutrition®
7955 Airport Pulling Road Suite 205
Naples, FL 34109
www.bexteranutrition.com
- Packaging
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INGREDIENTS AND APPEARANCE
BEXTERA HEALTH HAND SANITIZER
ethyl alcohol gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:77342-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 70 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H) TERT-BUTYL ALCOHOL (UNII: MD83SFE959) DENATONIUM BENZOATE (UNII: 4YK5Z54AT2) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:77342-101-01 500 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/05/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/05/2020 Labeler - Bextera Llc (117513250)