Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID eb89ec43-e0d6-4fd5-906e-65258e73dfb0
Route
TOPICAL
Published
Effective Date 2020-03-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Isopropyl Alcohol Glycerin Isopropyl Myristate Aloe Vera Leaf .alpha.-tocopherol Acetate, Dl- Carbomer 934 Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-03-13
Description

Ethyl Alcohol 65%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Uses

to help reduce bacteria on the skin. For use when soap and water are not available.

Warnings

For external use only.

  • flammable
  • keep away from source of heat or fire
Directions
  • put enough product in your palm to cover hands and rub hands together until dry.
  • children under 6 years should be supervised when using this product.
Label Copy

Do Not Use 
  • on children less than 2 months of age
  • on open skin wounds
Active Ingredient

Ethyl Alcohol 65%

Other Information
  • store at a temperature below 110°F (43°C).
  • may discolor certain fabrics or surfaces.
Inactive Ingredients

Water (Aqua), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

Label Copy 40 Fl Oz

Label Copy 64 Fl Oz

Questions Or Comments?

1-866-695-3030

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 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

to help reduce bacteria on the skin. For use when soap and water are not available.

Purpose

Antiseptic

Warnings

For external use only.

  • flammable
  • keep away from source of heat or fire
Directions
  • put enough product in your palm to cover hands and rub hands together until dry.
  • children under 6 years should be supervised when using this product.
Label Copy

Do Not Use  (Do not use )
  • on children less than 2 months of age
  • on open skin wounds
Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

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), Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum).

Label Copy 40 Fl Oz (Label Copy - 40 fl oz)

Label Copy 64 Fl Oz (Label Copy - 64 fl oz)

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 thoroughly 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: 2026-02-15T11:57:05.995973 · Updated: 2026-03-14T22:56:02.443544