Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID de3ee58d-48c7-4a23-b7bd-f0688192a709
Route
TOPICAL
Published
Effective Date 2017-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Isopropyl Alcohol .alpha.-glucan Oligosaccharide Aloe Vera Leaf Isopropyl Myristate Carbomer 934 .alpha.-tocopherol Acetate, Dl- Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-02-21

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: hands

Flammable. Keep away from fire or flame.

Directions
  • put enough product in your palm to cover hands and rub hand together until dry.
  • for children under 6, use only under adult supervision
  • not recommended for infants.
Label Copy

Active Ingredient

Ethyl Alcohol 65%

Other Information
  • store at a temperature below 110F (43C).
  • may discolor some fabrics.
Inactive Ingredients

Water (Aqua), Isopropyl Alcohol, Alpha-Glucan Oligosaccharaide, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Carbomer, Tocopheryl Acetate, Aminomethyl Propanol, Fragrance (Parfum).

When Using This Product

keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Stop Use and Ask A Doctor If
  • irritation or redness develops.
  • condition persists for more than 72 hours.
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses

to decrease bacteria on the skin.

Purpose

Antiseptic

Warnings

For external use only: hands

Flammable. Keep away from fire or flame.

Directions
  • put enough product in your palm to cover hands and rub hand together until dry.
  • for children under 6, use only under adult supervision
  • not recommended for infants.
Label Copy

Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

Other Information (Other information)
  • store at a temperature below 110F (43C).
  • may discolor some fabrics.
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Isopropyl Alcohol, Alpha-Glucan Oligosaccharaide, Glycerin, Aloe Barbadensis Leaf Juice, Isopropyl Myristate, Carbomer, Tocopheryl Acetate, Aminomethyl Propanol, Fragrance (Parfum).

When Using This Product (When using this product)

keep out of eyes. In case of contact with eyes, flush thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation or redness develops.
  • condition persists for more than 72 hours.
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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