Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID fb44fe16-5bc9-4ba9-88ce-05842376879c

Route

TOPICAL

Published

Effective Date 2011-10-25

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Alcohol (62 mL)

Inactive Ingredients

Water Glycerin Isopropyl Myristate Propylene Glycol .alpha.-tocopherol Acetate, D- Aminomethylpropanol Carbomer 934 Fd&c Red No. 4 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2011-10-25

Description

ETHYL ALCOHOL 62%

Purpose

ANTIMICROBIAL

Medication Information

Purpose

ANTIMICROBIAL

Description

ETHYL ALCOHOL 62%

Uses

HELPS REDUCE BACTERIA ON THE SKIN.

Warnings

FLAMMABLE, KEEP AWAY FROM FIRE.
FOR EXTERNAL USE ONLY.

Directions

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

Active Ingredient

ETHYL ALCOHOL 62%

Other Information

DO NOT STORE ABOVE 110 DEGREES FAHRENHEIT (43 DEGREES CELSIUS).

Inactive Ingredients

WATER (AQUA), GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, CARBOMER, FRAGRANCE, RED 4 (CI 14700), YELLOW 5 (CI 19140).

Front and Back Labels

When Using This Product

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

Keep Out of Reach of Children

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Stop Using This Product and Ask Doctor

IF IRRITATION AND REDNESS DEVELOP.

Structured Label Content

Uses (USES)

HELPS REDUCE BACTERIA ON THE SKIN.

Purpose (PURPOSE)

ANTIMICROBIAL

Warnings (WARNINGS)

FLAMMABLE, KEEP AWAY FROM FIRE.
FOR EXTERNAL USE ONLY.

Directions (DIRECTIONS)

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

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 62%

Other Information (OTHER INFORMATION)

DO NOT STORE ABOVE 110 DEGREES FAHRENHEIT (43 DEGREES CELSIUS).

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, CARBOMER, FRAGRANCE, RED 4 (CI 14700), YELLOW 5 (CI 19140).

Front and Back Labels (Front and back labels)

When Using This Product (WHEN USING THIS PRODUCT)

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

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

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

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

IF IRRITATION AND REDNESS DEVELOP.

Advanced Ingredient Data

[{"name": "ALCOHOL", "unii": "3K9958V90M", "classCode": "ACTIB", "strengthNumerator": "62", "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": "ISOPROPYL MYRISTATE", "unii": "0RE8K4LNJS", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE, D-", "unii": "A7E6112E4N", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "AMINOMETHYLPROPANOL", "unii": "LU49E6626Q", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER 934", "unii": "Z135WT9208", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 4", "unii": "X3W0AM1JLX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 5", "unii": "I753WB2F1M", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"USES": "HELPS REDUCE BACTERIA ON THE SKIN.", "PURPOSE": "ANTIMICROBIAL", "WARNINGS": "FLAMMABLE, KEEP AWAY FROM FIRE. FOR EXTERNAL USE ONLY.", "DIRECTIONS": "APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY. CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.", "ACTIVE INGREDIENT": "ETHYL ALCOHOL 62%", "OTHER INFORMATION": "DO NOT STORE ABOVE 110 DEGREES FAHRENHEIT (43 DEGREES CELSIUS).", "INACTIVE INGREDIENTS": "WATER (AQUA), GLYCERIN, ISOPROPYL MYRISTATE, PROPYLENE GLYCOL, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, CARBOMER, FRAGRANCE, RED 4 (CI 14700), YELLOW 5 (CI 19140).", "WHEN USING THIS PRODUCT": "AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THROUGHLY WITH WATER.", "KEEP OUT OF REACH OF CHILDREN": "IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.", "STOP USING THIS PRODUCT AND ASK DOCTOR": "IF IRRITATION AND REDNESS DEVELOP."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:21.146816 · Updated: 2026-03-14T22:52:53.430326