drug facts

drug facts
SPL v1
SPL
SPL Set ID a318857f-fa69-462d-9fed-b34199689ad3
Route
topical
Published
Effective Date 2018-02-01
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 glycerin aloe vera leaf isopropyl myristate carbomer 934 .alpha.-tocopherol acetate, dl- aminomethylpropanol

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2018-01-31

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 hands together until dry
  • for children under 6, use lonly under adult supervision
  • not recommended for infants
Other Information
  • store at atemperature below 110°F (43°C)
  • may discolor some fabrics
Inactive Ingredients

Water (Aqua), Isopropyl Alcohol, Alpha-Glucan Oligosaccharide, 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.

In case of accidental ingestion, 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 hands together until dry
  • for children under 6, use lonly under adult supervision
  • not recommended for infants
Other Information (Other information)
  • store at atemperature below 110°F (43°C)
  • may discolor some fabrics
Inactive Ingredients (Inactive ingredients)

Water (Aqua), Isopropyl Alcohol, Alpha-Glucan Oligosaccharide, 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.)

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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