Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 26b784a7-6391-4383-9d33-c70ef90799db
Route
TOPICAL
Published
Effective Date 2020-10-28
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- Acrylates/vinyl Isodecanoate Crosspolymer (10000 Mpa.s Neutralized At 0.5%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-10-06
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 bacterial, and can be used in place of hand washing if soap and water are not available.

59 Ml

236 Ml

444 Ml

946 Ml

Directions
  • For occasional and personal use
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry
  • Children under 6 years should be supervised when using this product
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
Other Information
  • store at a temperature below 110°F (43°C)
  • may discolor certain fabrics or surfaces
Active Ingredients

Ethyl Alcohol (65%)

Inactive Ingredients

Water, PEG-6, Fragrance, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer., Yellow 5 (Cl 19140), Blue 1 (Cl 42090)

For External Use Only
  • flammable
  • keep away from source of heat or fire
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 bacterial, and can be used in place of hand washing if soap and water are not available.

59 Ml (59 ml)

236 Ml (236 ml)

444 Ml (444 ml)

946 Ml (946 ml)

Purpose

Antiseptic

Directions
  • For occasional and personal use
  • Rub thoroughly into hands for at least 30 seconds. Allow to dry
  • Children under 6 years should be supervised when using this product
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
Other Information
  • store at a temperature below 110°F (43°C)
  • may discolor certain fabrics or surfaces
Active Ingredients

Ethyl Alcohol (65%)

Inactive Ingredients

Water, PEG-6, Fragrance, Isopropyl Alcohol, Glycerin, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, AMP-Acrylates/Vinyl Isodecanoate Crosspolymer., Yellow 5 (Cl 19140), Blue 1 (Cl 42090)

For External Use Only (For external use only)
  • flammable
  • keep away from source of heat or fire
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: 2026-02-15T11:58:57.668789 · Updated: 2026-03-14T22:58:46.689678