Antiseptique Advance Strength

SPL v1

SPL

SPL Set ID 28569ea5-29dc-4194-a898-cd7d0f44c24e

Route

TOPICAL

Published

Effective Date 2020-03-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Alcohol (80 mL)

Inactive Ingredients

Water Glycerin Hydrogen Peroxide

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2020-03-19

Description

Drug Facts

Purpose

Antiseptic handwash

Medication Information

Purpose

Antiseptic handwash

Description

Drug Facts

Uses

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

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 a doctor if skin irritation or rash occurs. There may be signs of a serious conditions.

Purposes

Antiseptic handwash

Warnings

For external use only
Flammable, keep away from heat or flame.

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

In eyes | on children less than 2 months old | on open skin wounds

Questions?

Email: [email protected]

Active Ingredient

Ethyl Alcohol 80% v/v

Other Information

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

Inactive Ingredients

Purified Water USP, Glycerin, Hydrogen Peroxide

When Using This Product

Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Principal Display Panel 59 Ml Bottle Label

ANTISEPTIQUE⁺

ADVANCED STRENGTH

sanitizer mist

Alcohol Antiseptic 80%

Topical Non-sterile Solution

2 FL. OZ. (59 ML)

Structured Label Content

Uses

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

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 a doctor if skin irritation or rash occurs. There may be signs of a serious conditions.

Purposes

Antiseptic handwash

Warnings

For external use only
Flammable, keep away from heat or flame.

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 (Do not use)

In eyes | on children less than 2 months old | on open skin wounds

Questions?

Email: [email protected]

Active Ingredient (Active ingredient)

Ethyl Alcohol 80% v/v

Other Information

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

Inactive Ingredients

Purified Water USP, Glycerin, Hydrogen Peroxide

When Using This Product (When using this product)

Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

ANTISEPTIQUE⁺

ADVANCED STRENGTH

sanitizer mist

Alcohol Antiseptic 80%

Topical 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": "Water", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Hydrogen Peroxide", "unii": "BBX060AN9V", "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 a doctor if skin irritation or rash occurs. There may be signs of a serious conditions.", "Purposes": "Antiseptic handwash", "Warnings": "For external use only Flammable, keep away from heat or flame.", "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": "In eyes | on children less than 2 months old | on open skin wounds", "Questions?": "Email: sales@tri-pac.us", "Active ingredient": "Ethyl Alcohol 80% v/v", "Other Information": "Store between 15-30°C (59-86°F), Avoid freezing and excessive heat above 40°C (104°F)", "Inactive Ingredients": "Purified Water USP, Glycerin, Hydrogen Peroxide", "When using this product": "Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.", "PRINCIPAL DISPLAY PANEL - 59 ML Bottle Label": "ANTISEPTIQUE + ADVANCED STRENGTH sanitizer mist Alcohol Antiseptic 80% Topical Non-sterile Solution 2 FL. OZ. (59 ML)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:05.910741 · Updated: 2026-03-14T22:56:00.983918