drug facts

drug facts
SPL v1
SPL
SPL Set ID e269b9a9-ed74-4351-907f-9285416ae31f
Route
topical
Published
Effective Date 2017-05-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (700 mg)
Inactive Ingredients
water carbomer 934 glycerin isopropyl myristate isopropyl alcohol aminomethylpropanol aloe vera leaf .alpha.-tocopherol acetate, dl- fd&c blue no. 1 fd&c yellow no. 5

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-05-04

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), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Myristate, Isopropyl Alcohol, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Blue 1 (CI 42090), Yellow 5 (CI 19140).

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 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

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), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Myristate, Isopropyl Alcohol, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Blue 1 (CI 42090), Yellow 5 (CI 19140).

Use

to help reduce bacteria on the skin.

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 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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