drug facts

drug facts
SPL v1
SPL
SPL Set ID 699b46e4-d352-4bf5-bef5-6f108f7e078f
Route
topical
Published
Effective Date 2016-08-22
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 2016-08-18

Purpose

Antiseptic

Description

Ethyl Alcohol 70% (v/v)


Medication Information

Warnings

For external use only.

  • Flammable.
  • Keep away from source of heat or fire.
Purpose

Antiseptic

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.
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).

Description

Ethyl Alcohol 70% (v/v)

Use

to help reduce bacteria on the skin.

Label Copy

Active Ingredient

Ethyl Alcohol 70% (v/v)

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

Warnings

For external use only.

  • Flammable.
  • Keep away from source of heat or fire.
Purpose

Antiseptic

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.
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).

Use

to help reduce bacteria on the skin.

Label Copy (Label copy)

Active Ingredient (Active ingredient)

Ethyl Alcohol 70% (v/v)

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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