drug facts

drug facts
SPL v1
SPL
SPL Set ID b53e8d23-22cc-4e3b-81ad-77777821a1ee
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 mannitol powdered cellulose .alpha.-tocopherol acetate, dl- hypromelloses chromium hydroxide green fd&c blue no. 1 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-04-25

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
  • 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.
Inactive Ingredients

Water (Aqua), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Mannitol, Cellulose, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Chromium Hydroxide Green (CI 77289), Blue 1 (CI 42090), Yellow 5 (CI 19140).

Description

Ethyl Alcohol 65%

Label Copy

Active Ingredient

Ethyl Alcohol 65%

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
  • 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.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Mannitol, Cellulose, Tocopheryl Acetate, Hydroxypropyl Methylcellulose, Chromium Hydroxide Green (CI 77289), Blue 1 (CI 42090), Yellow 5 (CI 19140).

Label Copy

Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

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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