76370-0034 Tazza-x Extreme 63% Alcohol Formula Hand Sanitizing Gel

SPL v2

SPL

SPL Set ID 3a073e9c-d6e6-e2d9-e063-6394a90a6153

Route

TOPICAL

Published

Effective Date 2025-07-18

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (63 mL)

Inactive Ingredients

Triethanolamine .alpha.-tocopherol Carbomer Glycerin Aloe Vera Leaf Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Active Ingredient Ethanol 63% v/v

Medication Information

Warnings and Precautions

Warnings

· Flammable: Keep away from flame or high heat.

· For external use only.

· When using this product keep out of eyes. Stop use and ask a

doctor if redness or irritation develops.

Indications and Usage

Uses Decreases bacteria on hands

Dosage and Administration

Directions

· Dispense an adequate amount in your palm

to cover all surfaces of both hands completely.

· Rub hands together until dry.

Description

Active Ingredient Ethanol 63% v/v

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

Purified Water, Glycerin, Triethanolamine,

Carbomer, Vitamin E, Aloe Vera.

Section 51945-4

NET 16.9 FL. OZ.

(500ML)

NDC: 76370-0034-0

Section 55105-1

Purpose

Antiseptic

Section 55106-9

Active Ingredient

Ethanol 63% v/v

Structured Label Content

Indications and Usage (34067-9)

Uses Decreases bacteria on hands

Dosage and Administration (34068-7)

Directions

· Dispense an adequate amount in your palm

to cover all surfaces of both hands completely.

· Rub hands together until dry.

Warnings and Precautions (34071-1)

Warnings

· Flammable: Keep away from flame or high heat.

· For external use only.

· When using this product keep out of eyes. Stop use and ask a

doctor if redness or irritation develops.

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

Purified Water, Glycerin, Triethanolamine,

Carbomer, Vitamin E, Aloe Vera.

Section 51945-4 (51945-4)

NET 16.9 FL. OZ.

(500ML)

NDC: 76370-0034-0

Section 55105-1 (55105-1)

Purpose

Antiseptic

Section 55106-9 (55106-9)

Active Ingredient

Ethanol 63% v/v

Advanced Ingredient Data

[{"name": "TRIETHANOLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL", "unii": "H4N855PNZ1", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER", "unii": "0A5MM307FC", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "63", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Decreases bacteria on hands", "34068-7": "Directions · Dispense an adequate amount in your palm to cover all surfaces of both hands completely. · Rub hands together until dry.", "34071-1": "Warnings · Flammable: Keep away from flame or high heat. · For external use only. · When using this product keep out of eyes. Stop use and ask a doctor if redness or irritation develops.", "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 Purified Water, Glycerin, Triethanolamine, Carbomer, Vitamin E, Aloe Vera.", "51945-4": "NET 16.9 FL. OZ. (500ML) NDC: 76370-0034-0", "55105-1": "Purpose Antiseptic", "55106-9": "Active Ingredient Ethanol 63% v/v"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:53.425682 · Updated: 2026-03-14T23:11:51.346073