BEXTERA HEALTH HAND SANITIZER- ethyl alcohol gel 
Bextera Llc

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.

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Bextera HEALTH HAND SANITIZER

Drug Facts

Active ingredient

Ethyl Alcohol 70% v/v

Purpose

Antimicrobial

Use • Hand sanitizer to help reduce bacteria on the skin

Warnings

Flammable. Keep away from fire or flame.

For external use only.

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.

Directions • Put enough product in your palm to cover hands and rub hands together briskly until dry

• Children under 6 years old should be supervised when using this product

Other information Store below 1100F (430C)

• May discolor certain fabrics or surfaces

Inactive ingredients  Water, methyl cellulose, tertiary butyl alcohol (denaturant), denatonium benzoate.

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

untitled

BEXTERA HEALTH HAND SANITIZER 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77342-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
METHYLCELLULOSE, UNSPECIFIED (UNII: Z944H5SN0H)  
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77342-101-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/05/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/05/2020
Labeler - Bextera Llc (117513250)

Revised: 5/2020
Document Id: 6cd234e0-c8ca-44a6-b82f-76b26120a719
Set id: 81d88b01-71f6-43f9-9849-3d4b358ac6c5
Version: 1
Effective Time: 20200507
 
Bextera Llc