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

Purpose

Antiseptic

Description

Ethyl Alcohol 65%


Medication Information

Warnings

For external use only: hands

Flammable. Keep away from fire or flame.

Uses

to decrease bacteria on the skin.

Purpose

Antiseptic

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.
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).

Description

Ethyl Alcohol 65%

Label Copy

Active Ingredient

Ethyl Alcohol 65%

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

Warnings

For external use only: hands

Flammable. Keep away from fire or flame.

Uses

to decrease bacteria on the skin.

Purpose

Antiseptic

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.
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).

Label Copy

Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

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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