Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID a1402189-c30a-429b-90a4-cbd0bcdfe223
Route
TOPICAL
Published
Effective Date 2020-07-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (650 mg)
Inactive Ingredients
Water Polyethylene Glycol 300 Isopropyl Alcohol Glycerin Isopropyl Myristate Aloe Vera Leaf .alpha.-tocopherol Acetate, Dl-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-13
Description

Ethyl Alcohol 65%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 65%

Uses

for personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Warnings

For external use only

  • flammable
  • keep away from source of heat or fire
Directions
  • Adults only
  • For occasional and personal use
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry
Do Not Use
  • on children less than 2 months of age
  • on open skin wounds
  • on broken or damaged skin
  • if you are pregnant or breastfeeding
Label Copy

Active Ingredient

Ethyl Alcohol 65%

Other Information
  • store at a temperature below 110°F (43°C)
  • may discolor certain fabrics or surfaces
Inactive Ingredients

Water, PEG-6, Fragrance, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer.

Questions Or Comments?

1-866-695-3030

When Using This Product

avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not inhale.

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

Uses

for personal hand hygiene to help prevent the spread of bacteria, and can be used in place of hand washing if soap and water are not available.

Purpose

Antiseptic

Warnings

For external use only

  • flammable
  • keep away from source of heat or fire
Directions
  • Adults only
  • For occasional and personal use
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry
Do Not Use (Do not use)
  • on children less than 2 months of age
  • on open skin wounds
  • on broken or damaged skin
  • if you are pregnant or breastfeeding
Label Copy (Label copy)

Active Ingredient (Active ingredient)

Ethyl Alcohol 65%

Other Information (Other information)
  • store at a temperature below 110°F (43°C)
  • may discolor certain fabrics or surfaces
Inactive Ingredients (Inactive ingredients)

Water, PEG-6, Fragrance, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer.

Questions Or Comments? (Questions or comments?)

1-866-695-3030

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not inhale.

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:11.885746 · Updated: 2026-03-14T22:57:38.360001