Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ccdde942-160c-467c-8bd3-cbc102b18a04
Route
TOPICAL
Published
Effective Date 2018-04-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-04-13

Description

Ethyl Alcohol 65%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Uses

to help reduce bacteria on the skin.

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

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, Alpha-Glucan Oligosaccharide, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Carbomer, Tocopheryl Acetate, Aminomethyl Propanol, Fragrance (Parfum).

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 acidental ingestion, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Uses

to help reduce bacteria on the skin.

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

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, Alpha-Glucan Oligosaccharide, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Carbomer, Tocopheryl Acetate, Aminomethyl Propanol, Fragrance (Parfum).

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 acidental ingestion, get medical help or contact a Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

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