Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID a1d0aeac-6497-492e-8b9a-beb2ab6b39f9

Route

TOPICAL

Published

Effective Date 2013-10-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (650 mg)

Inactive Ingredients

Water Isopropyl Alcohol Glycerin Carbomer 934 Aminomethylpropanol Propylene Glycol Isopropyl Myristate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2013-10-02

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

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

Other Information

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

Inactive Ingredients

WATER (AQUA), ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE.

When Using This Product

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)

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.

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), ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE.

When Using This Product (WHEN USING THIS PRODUCT)

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": "ISOPROPYL ALCOHOL", "unii": "ND2M416302", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "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": "WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY.", "ACTIVE INGREDIENT": "ETHYL ALCOHOL 65%", "OTHER INFORMATION": "STORE AT A TEMPERATURE BELOW 110°F (43°C).", "INACTIVE INGREDIENTS": "WATER (AQUA), ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE (PARFUM), PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE.", "WHEN USING THIS PRODUCT": "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: 2026-02-15T11:55:42.459196 · Updated: 2026-03-14T22:53:35.925326