SPL v1
SPL
SPL Set ID 46e95fb5-52dd-45bf-a320-d502921b09f6
Route
TOPICAL
Published
Effective Date 2015-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Propylene Glycol Sulisobenzone Carbomer 934 Glycerin Aminomethylpropanol Isopropyl Alcohol Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2015-01-12
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, 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

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, BLUE 1 (CI 42090), RED 33 (CI 17200)

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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:53.082600 · Updated: 2026-03-14T22:53:55.198203