drug facts

drug facts
SPL v1
SPL
SPL Set ID ef783222-3547-49fa-b6a4-d6f5d369a9d9
Route
topical
Published
Effective Date 2017-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (650 mg)
Inactive Ingredients
water carbomer 934 aminomethylpropanol .alpha.-tocopherol acetate, dl- isopropyl alcohol isopropyl myristate aloe vera leaf glycerin d&c red no. 33 fd&c blue no. 1

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-05-22

Purpose

Antiseptic

Description

Ethyl Alcohol 65%


Medication Information

Warnings

For external use only

  • Flammable
  • Keep away from source of heat or fire
Uses

to decrease bacteria on the skin.

Purpose

Antiseptic

Directions
  • apply a small amount to your palm and rub hands together briskly until dry.
  • children 6 years of age and under should be supervised when using this product.
Other Information

store at a temperature below 110°F (43°C)

Inactive Ingredients

Water (Aqua), Fragrance (Parfum), Carbomer, Aminomethyl Propanol, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Glycerin, Red 33 (CI 17200), Blue 1 (CI 42090).

Description

Ethyl Alcohol 65%

Label Copy

Active Ingredient

Ethyl Alcohol 65%

Questions Or Comments?

1-800-934-6267

When Using This Product

avoid contact with eyes. If contact occurs, rinse 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

Warnings

For external use only

  • Flammable
  • Keep away from source of heat or fire
Uses

to decrease bacteria on the skin.

Purpose

Antiseptic

Directions
  • apply a small amount to your palm and rub hands together briskly until dry.
  • children 6 years of age and under should be supervised when using this product.
Other Information (Other information)

store at a temperature below 110°F (43°C)

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Fragrance (Parfum), Carbomer, Aminomethyl Propanol, Tocopheryl Acetate, Isopropyl Alcohol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Glycerin, Red 33 (CI 17200), Blue 1 (CI 42090).

Label Copy

Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

Questions Or Comments? (Questions or comments?)

1-800-934-6267

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse 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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