Bextera Health Hand Sanitizer

SPL v1

SPL

SPL Set ID 81d88b01-71f6-43f9-9849-3d4b358ac6c5

Route

TOPICAL

Published

Effective Date 2020-05-13

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (70 mL)

Inactive Ingredients

Water Methylcellulose, Unspecified Tert-butyl Alcohol Denatonium Benzoate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-05-05

Description

Active ingredient Ethyl Alcohol 70% v/v

Medication Information

Warnings and Precautions

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.

Indications and Usage

Use • Hand sanitizer to help reduce bacteria on the skin

Dosage and 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

Description

Active ingredient Ethyl Alcohol 70% v/v

Section 42229-5

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

Section 44425-7

Other information • Store below 110⁰F (43⁰C)

• May discolor certain fabrics or surfaces

Section 50565-1

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

Section 51727-6

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

Section 55105-1

Purpose

Antimicrobial

Section 55106-9

Active ingredient

Ethyl Alcohol 70% v/v

Packaging

Drug Facts

Structured Label Content

Indications and Usage (34067-9)

Use • Hand sanitizer to help reduce bacteria on the skin

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.

Section 42229-5 (42229-5)

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

Section 44425-7 (44425-7)

Other information • Store below 110⁰F (43⁰C)

• May discolor certain fabrics or surfaces

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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

Section 55105-1 (55105-1)

Purpose

Antimicrobial

Section 55106-9 (55106-9)

Active ingredient

Ethyl Alcohol 70% v/v

Packaging

Drug Facts

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "70", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLCELLULOSE, UNSPECIFIED", "unii": "Z944H5SN0H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TERT-BUTYL ALCOHOL", "unii": "MD83SFE959", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DENATONIUM BENZOATE", "unii": "4YK5Z54AT2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Use • Hand sanitizer to help reduce bacteria on the skin", "34068-7": "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", "34071-1": "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.", "42229-5": "ANTI BACTERIAL ANTI VIRAL 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", "44425-7": "Other information • Store below 110 0 F (43 0 C) • May discolor certain fabrics or surfaces", "50565-1": "Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center right away.", "51727-6": "Inactive ingredients Water, methyl cellulose, tertiary butyl alcohol (denaturant), denatonium benzoate.", "55105-1": "Purpose Antimicrobial", "55106-9": "Active ingredient Ethyl Alcohol 70% v/v"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:34.213834 · Updated: 2026-03-14T22:56:48.082967