SPL v1
SPL
SPL Set ID 2b949b7c-70d9-439e-9dfb-552e2d1b34f0
Route
TOPICAL
Published
Effective Date 2020-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (65 mL)
Inactive Ingredients
Water Glycerin Carbomer Copolymer Type A Aminomethylpropanol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-06-02
Description

Ethyl Alcohol 65% 

Purpose

 Antiseptic

Medication Information

Purpose

 Antiseptic

Description

Ethyl Alcohol 65% 

use
  • Hand sanitizer to help decrease bacteria on the skin  
  • when water, soap & towel are not available
  • Recommended for repeated use.
Section 42229-5

Other information

  • Store between 68-77℉ (20-25℃)
  • May discolor fabrics.
Warnings

For external use only.

Flammable,

Keep away from fire or flame

Do not apply around eyes, do not use in ears and mouth.

When using this product

avoid contact with eyes. In case of contact, rinse eyes with water immediately

Stop use and ask a doctor if

redness or irritation develop and persist for more than 72 hours

Packaging

directions
  • Pump as needed into your palms and thoroughly spread on both hands
  • Rub into skin until dry.
Active Ingredient

Ethyl Alcohol 65% 

Inactive Ingredients

Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance

Keep Out of Reach of Children.

Children must be supervised in use of this product.

Structured Label Content

use (Use)
  • Hand sanitizer to help decrease bacteria on the skin  
  • when water, soap & towel are not available
  • Recommended for repeated use.
Section 42229-5 (42229-5)

Other information

  • Store between 68-77℉ (20-25℃)
  • May discolor fabrics.
Purpose

 Antiseptic

Warnings

For external use only.

Flammable,

Keep away from fire or flame

Do not apply around eyes, do not use in ears and mouth.

When using this product

avoid contact with eyes. In case of contact, rinse eyes with water immediately

Stop use and ask a doctor if

redness or irritation develop and persist for more than 72 hours

Packaging

directions (Directions)
  • Pump as needed into your palms and thoroughly spread on both hands
  • Rub into skin until dry.
Active Ingredient (Active ingredient)

Ethyl Alcohol 65% 

Inactive Ingredients (Inactive ingredients)

Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance

Keep Out of Reach of Children. (Keep out of reach of children.)

Children must be supervised in use of this product.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:57:46.359630 · Updated: 2026-03-14T22:57:01.531445