Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 83811bb0-d288-47f1-9818-1a084d2e8004
Route
TOPICAL
Published
Effective Date 2017-05-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (700 mg)
Inactive Ingredients
Water Carbomer 934 Glycerin Isopropyl Myristate Isopropyl Alcohol Aminomethylpropanol Aloe Vera Leaf .alpha.-tocopherol Acetate, Dl- Fd&c Red No. 4 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-05-17

Description

Ethyl Alcohol 70%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70%

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 70%

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

Water (Aqua), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Myristate, Isopropyl Alcohol, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Red 4 (CI 14700), Yellow 5 (CI 19140).

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.

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 70%

Other Information (Other information)
  • store at a temperature below 110°F (43°C).
  • May discolor some fabrics or surfaces.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Myristate, Isopropyl Alcohol, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Red 4 (CI 14700), Yellow 5 (CI 19140).

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

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