Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 0f358a55-2e9e-49c3-a534-f7f83343228f
Route
TOPICAL
Published
Effective Date 2017-04-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Carbomer 934 Glycerin Isopropyl Alcohol Isopropyl Myristate Aminomethylpropanol Aloe Vera Leaf Synthetic Wax (1800 Mw) Microcrystalline Wax .alpha.-tocopherol Acetate, Dl- Hypromelloses Fd&c Blue No. 1 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-04-25

Description

Ethyl Alcohol 65%

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Uses

to decrease 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%

Inactive Ingredients

Water (Aqua), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Synthetic Wax, Microcrystalline Wax, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Blue 1 Lake (CI 42090), Yellow 5 (CI 19140).

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

Uses

to decrease 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%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Synthetic Wax, Microcrystalline Wax, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Blue 1 Lake (CI 42090), Yellow 5 (CI 19140).

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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