drug facts

drug facts
SPL v1
SPL
SPL Set ID c3424a1b-578c-4a15-8c42-8dfbd80ed7a2
Route
topical
Published
Effective Date 2015-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (650 mg)
Inactive Ingredients
water propylene glycol isopropyl alcohol carbomer 934 aminomethylpropanol glycerin sulisobenzone high density polyethylene ultramarine blue fd&c blue no. 1 d&c red no. 33

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2015-03-03
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 DECREASE BACTERIA ON THE SKIN

Purpose

ANTISEPTIC

Directions
  • PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HAND TOGETHER UNTIL DRY
  • CHIDREN UNDER 6 YEARS SHOULD BE SUPERVISED WHEN USING THIS PRODUCT
Other Information
  • STORE AT A TEMPERATURE BELOW 110°F (43°C)
  • MAY DISCOLOR CERTAIN FABRICS OR SURFACES
Inactive Ingredients

WATER (AQUA), PROPYLENE GLYCOL, ISOPROPYL ALCOHOL, CARBOMER, AMINOMETHYL PROPANOL, GLYCERIN, FRAGRANCE (PARFUM), BENZOPHENONE-4, POLYETHYLENE, ULTRAMARINES (CI 77007), BLUE 1 (CI 42090), RED 33 (CI 17200)

Description

ETHYL ALCOHOL 65%

Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH THOROUGHLY 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 and Ask A 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 DECREASE BACTERIA ON THE SKIN

Purpose (PURPOSE)

ANTISEPTIC

Directions (DIRECTIONS)
  • PUT ENOUGH PRODUCT IN YOUR PALM TO COVER HANDS AND RUB HAND TOGETHER UNTIL DRY
  • CHIDREN UNDER 6 YEARS SHOULD BE SUPERVISED WHEN USING THIS PRODUCT
Other Information (OTHER INFORMATION)
  • STORE AT A TEMPERATURE BELOW 110°F (43°C)
  • MAY DISCOLOR CERTAIN FABRICS OR SURFACES
Inactive Ingredients (INACTIVE INGREDIENTS)

WATER (AQUA), PROPYLENE GLYCOL, ISOPROPYL ALCOHOL, CARBOMER, AMINOMETHYL PROPANOL, GLYCERIN, FRAGRANCE (PARFUM), BENZOPHENONE-4, POLYETHYLENE, ULTRAMARINES (CI 77007), BLUE 1 (CI 42090), RED 33 (CI 17200)

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

When Using This Product (WHEN USING THIS PRODUCT)

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH THOROUGHLY 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 and Ask A Doctor If (STOP USING AND ASK A DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS AND LASTS

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:54.841820 · Updated: 2026-03-14T22:53:57.959732