Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID ad8cedc6-43ca-4cdb-be28-a69727d5f9b9

Route

TOPICAL

Published

Effective Date 2014-11-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (650 mg)

Inactive Ingredients

Water Propylene Glycol Sulibenzone Carbomer 934 Glycerin Aminomethylpropanol Isopropyl Alcohol Fd&c Yellow No. 5 Fd&c Red No. 40

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2014-11-23

Description

ETHYL ALCOHOL 65%

Purpose

ANTISEPTIC

Medication Information

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%

Uses

TO DECREASE BACTERIA ON THE SKIN

Warnings

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE

Directions

APPLY A SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN 6 YEARS OF AGE AND UNDER SHOULD BE SUPERVISED WHEN USING THIS PRODUCT

Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

Other Information

STORE AT A TEMPERATURE BELOW 110°F (43°C)

Inactive Ingredients

WATER (AQUA), PROPYLENE GLYCOL, FRAGRANCE (PARFUM), BENZOPHENONE-4, CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, ISOPROPYL ALCOHOL, YELLOW 5 (CI 19140), RED 40 (CI 16035)

Questions Or Comments?

1-800-934-6267

When Using This Section

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER

Stop Use and Ask A Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Structured Label Content

Uses (USES)

TO DECREASE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTISEPTIC

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE

Directions (DIRECTIONS)

APPLY A SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN 6 YEARS OF AGE AND UNDER SHOULD BE SUPERVISED WHEN USING THIS PRODUCT

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Other Information (OTHER INFORMATION)

STORE AT A TEMPERATURE BELOW 110°F (43°C)

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), PROPYLENE GLYCOL, FRAGRANCE (PARFUM), BENZOPHENONE-4, CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, ISOPROPYL ALCOHOL, YELLOW 5 (CI 19140), RED 40 (CI 16035)

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-934-6267

When Using This Section (WHEN USING THIS SECTION)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS AND LASTS

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "650", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SULIBENZONE", "unii": "853Z42ZYAS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "TO DECREASE BACTERIA ON THE SKIN", "PURPOSE": "ANTISEPTIC", "WARNINGS": "FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM SOURCE OF HEAT OR FIRE", "DIRECTIONS": "APPLY A SMALL AMOUNT TO YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN 6 YEARS OF AGE AND UNDER SHOULD BE SUPERVISED WHEN USING THIS PRODUCT", "ACTIVE INGREDIENT": "ETHYL ALCOHOL 65%", "OTHER INFORMATION": "STORE AT A TEMPERATURE BELOW 110°F (43°C)", "INACTIVE INGREDIENTS": "WATER (AQUA), PROPYLENE GLYCOL, FRAGRANCE (PARFUM), BENZOPHENONE-4, CARBOMER, GLYCERIN, AMINOMETHYL PROPANOL, ISOPROPYL ALCOHOL, YELLOW 5 (CI 19140), RED 40 (CI 16035)", "QUESTIONS OR COMMENTS?": "1-800-934-6267", "WHEN USING THIS SECTION": "AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER", "STOP USE AND ASK A DOCTOR IF": "IRRITATION OR REDNESS DEVELOPS AND LASTS", "KEEP OUT OF REACH OF CHILDREN": "IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:51.670552 · Updated: 2026-03-14T22:53:53.333843