Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 61cf97dd-78a2-4355-a7e9-8cb6b63553a4
Route
TOPICAL
Published
Effective Date 2017-01-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (700 mg)
Inactive Ingredients
Water Isopropyl Alcohol Aloe Vera Leaf Propylene Glycol Glycerin Isopropyl Myristate .alpha.-tocopherol Acetate, Dl- Carbomer Copolymer Type A (allyl Pentaerythritol Crosslinked) Aminomethylpropanol Ethylhexylglycerin Fd&c Yellow No. 5 Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-01-20

Description

Ethyl Alcohol 70% (v/v)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% (v/v)

Use

to help reduce bacteria on the skin.

Warnings

For external use only.

Flammable. Keep away from source of heat or fire.

Directions
  • Put enough hand sanitizer 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% (v/v)

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

Water (Aqua), Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Propylene Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Ethylhexylglycerin, Yellow 5 (CI 19140), Blue 1 (CI 42090).

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 persists.

Keep Out of Reach of Children.

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.


Structured Label Content

Use

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 hand sanitizer 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% (v/v)

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, Aloe Barbadensis Leaf Juice, Propylene Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance (Parfum), Ethylhexylglycerin, Yellow 5 (CI 19140), Blue 1 (CI 42090).

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 persists.

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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