hand sanitizer

SPL v1

SPL

SPL Set ID 18eda412-4d14-45db-84c9-d6cdad10ee87

Route

topical

Published

Effective Date 2020-08-27

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

alcohol (80 mL)

Inactive Ingredients

glycerin hydrogen peroxide water

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2020-03-31

Purpose

Antiseptic

Description

DRUG FACTS

Medication Information

Warnings

For external use only. Flammable. Keep away from fire or flames.

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

Antiseptic

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15-30° C (59-86°F)
Avoid freezing and excessive heat above 40° (104°F)

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Description

DRUG FACTS

Section 42229-5

DRUG FACTS

Section 50565-1

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

Section 50566-9

Stop use and ask doctor if redness or irritation develop. These may be signs of a serious condition.

Section 50567-7

When using this product avoid contact with eyes, ears and mouth. In case of contact flush eyes with water.

Do Not Use

on children less than 2 months of age
on open skin wounds

Active Ingredient

Ethyl Alcohol 80%

Principal Display Panel 59 Ml Bottle Label

GINESIS

Alcohol Antiseptic 80%

Topical Solution

Hand Sanitizer

Non-Sterile Solution

2 FL OZ. (59 ML)

Structured Label Content

Warnings

For external use only. Flammable. Keep away from fire or flames.

Uses

Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

Antiseptic

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information (Other information)

Store between 15-30° C (59-86°F)
Avoid freezing and excessive heat above 40° (104°F)

Inactive Ingredients (Inactive ingredients)

glycerin, hydrogen peroxide, purified water USP

Section 42229-5 (42229-5)

DRUG FACTS

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 50566-9 (50566-9)

Stop use and ask doctor if redness or irritation develop. These may be signs of a serious condition.

Section 50567-7 (50567-7)

When using this product avoid contact with eyes, ears and mouth. In case of contact flush eyes with water.

Do Not Use (Do not use)

on children less than 2 months of age
on open skin wounds

Active Ingredient (Active ingredient)

Ethyl Alcohol 80%

Principal Display Panel 59 Ml Bottle Label (PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label)

GINESIS

Alcohol Antiseptic 80%

Topical Solution

Hand Sanitizer

Non-Sterile Solution

2 FL OZ. (59 ML)

Advanced Ingredient Data

[{"name": "Alcohol", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "80", "strengthDenominator": "100", "strengthNumeratorUnit": "mL", "strengthDenominatorUnit": "mL"}, {"name": "glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "hydrogen peroxide", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.", "42229-5": "DRUG FACTS", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask doctor if redness or irritation develop. These may be signs of a serious condition.", "50567-7": "When using this product avoid contact with eyes, ears and mouth. In case of contact flush eyes with water.", "Purpose": "Antiseptic", "Warnings": "For external use only. Flammable. Keep away from fire or flames.", "Directions": "Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.", "Do not use": "on children less than 2 months of age on open skin wounds", "Active ingredient": "Ethyl Alcohol 80%", "Other information": "Store between 15-30° C (59-86°F) Avoid freezing and excessive heat above 40° (104°F)", "Inactive ingredients": "glycerin, hydrogen peroxide, purified water USP", "PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label": "GINESIS Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution 2 FL OZ. (59 ML)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:34.596161 · Updated: 2026-03-14T22:58:10.333472