drug facts

drug facts

SPL v1

SPL

SPL Set ID fc640d39-9b6d-43dd-94fe-6dd72772bb0a

Route

topical

Published

Effective Date 2015-01-14

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

alcohol (650 mg)

Inactive Ingredients

water propylene glycol sulisobenzone carbomer 934 glycerin .alpha.-tocopherol acetate aminomethylpropanol isopropyl myristate fd&c blue no. 1 d&c red no. 33

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 DECREASE BACTERIA ON THE SKIN

Purpose

ANTISEPTIC

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

Other Information

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

Inactive Ingredients

WATER (AQUA), PROPYLENE GLYCOL, FRAGRANCE (PARFUM), BENZOPHENONE-4, CARBOMER, GLYCEIRN, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, ISOPROPYL MYRISTATE, BLUE 1 (CI 42090), RED 33 (CI 17200)

Description

ETHYL ALCOHOL 65%

Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

Questions Or Comments?

1-866-695-3030

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

Warnings (WARNINGS)

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

Uses (USES)

TO DECREASE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTISEPTIC

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

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, GLYCEIRN, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, ISOPROPYL MYRISTATE, BLUE 1 (CI 42090), RED 33 (CI 17200)

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-866-695-3030

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": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SULISOBENZONE", "unii": "1W6L629B4K", "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": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "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, GLYCEIRN, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, ISOPROPYL MYRISTATE, BLUE 1 (CI 42090), RED 33 (CI 17200)", "QUESTIONS OR COMMENTS?": "1-866-695-3030", "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

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Source: dailymed · Ingested: 2026-02-15T11:55:53.091966 · Updated: 2026-03-14T22:53:55.198203