drug facts

drug facts
SPL v1
SPL
SPL Set ID 930ab422-bd7d-4875-b28e-d2e4aadd3637
Route
topical
Published
Effective Date 2015-04-28
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 sulisobenzone glycerin d&c red no. 33

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2015-04-27

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 YOU PALM TO COVER HANDS AND RUB HANDS TOGETHER UNTIL DRY
  • CHILDREN 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, BENZOPHENONE-4, GLYCERIN, FRAGRANCE (PARFUM), RED 33 (CI 17200)

Description

ETHYL ALCOHOL 65%

Label Copy

Active Ingredient

ETHYL ALCOHOL 65%

Questions Or Comments?

1-800-842-7886

When Using This Product

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

Stop Use and Ask A Doctor If

IRRITATION OR REDNESS DEVELOPS OR LASTS

Keep Out of Reach of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. 1-800-222-1222


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 YOU PALM TO COVER HANDS AND RUB HANDS TOGETHER UNTIL DRY
  • CHILDREN 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, BENZOPHENONE-4, GLYCERIN, FRAGRANCE (PARFUM), RED 33 (CI 17200)

Label Copy (LABEL COPY)

Active Ingredient (ACTIVE INGREDIENT)

ETHYL ALCOHOL 65%

Questions Or Comments? (QUESTIONS OR COMMENTS?)

1-800-842-7886

When Using This Product (WHEN USING THIS PRODUCT)

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

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

IRRITATION OR REDNESS DEVELOPS OR 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. 1-800-222-1222


Advanced Ingredient Data


Raw Label Data

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