Bextera Health Hand Sanitizer
FDA Label NDC 77342-101
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bextera Llc for the product Bextera Health Hand Sanitizer (NDC 77342-101). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Ethyl Alcohol 70% v/v
Otc - Purpose
Purpose
Antimicrobial
Indications & Usage
Use • Hand sanitizer to help reduce bacteria on the skin
Warnings
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
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
Storage And Handling
Other information • Store below 1100F (430C)
• May discolor certain fabrics or surfaces
Inactive Ingredient
Inactive ingredients Water, methyl cellulose, tertiary butyl alcohol (denaturant), denatonium benzoate.
Other
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
* Please review the disclaimer below.