drug facts

drug facts

SPL v1

SPL

SPL Set ID bca300d1-06ca-4e4f-a07a-3afa37a4ae4a

Route

topical

Published

Effective Date 2015-05-12

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 2015-01-13

Purpose

ANTISEPTIC

Description

ETHYL ALCOHOL 65%

Medication Information

Warnings

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

Uses

TO HELP REDUCE BACTERIA ON THE SKIN

Purpose

ANTISEPTIC

Directions

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY

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

Description

ETHYL ALCOHOL 65%

Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

Questions Or Comments?

1-800-934-1204

When Using This Product

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

Keep Out of Reach of Children

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

Stop Using This Product and Ask Doctor If

IRRITATION OR REDNESS DEVELOPS AND LASTS

Structured Label Content

Warnings (WARNINGS)

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

Uses (USES)

TO HELP REDUCE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTISEPTIC

Directions (DIRECTIONS)

WET HANDS THOROUGHLY AND RUB TOGETHER UNTIL DRY

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

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-934-1204

When Using This Product (WHEN USING THIS PRODUCT)

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

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

Stop Using This Product and Ask Doctor If (STOP USING THIS PRODUCT AND ASK DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS AND LASTS

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 HELP REDUCE 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", "QUESTIONS OR COMMENTS?": "1-800-934-1204", "WHEN USING THIS PRODUCT": "AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER", "KEEP OUT OF REACH OF CHILDREN": "IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY", "STOP USING THIS PRODUCT AND ASK DOCTOR IF": "IRRITATION OR REDNESS DEVELOPS AND LASTS"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:56.723015 · Updated: 2026-03-14T22:53:59.906934