1ae0183e-c360-411c-ad11-c7ffc14fe349

SPL v2
SPL
SPL Set ID 1ae0183e-c360-411c-ad11-c7ffc14fe349
Route
topical
Published
Effective Date 2020-07-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 mL)
Inactive Ingredients
propylene glycol water carbomer 940 monoethanolamine

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2020-06-27
Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v.

Medication Information

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

in children less than 2 months of age

on open skin wounds



When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

Antiseptic

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Adult supervision for children under 6 years of age when using this product to avoide swallowing.
  • Not recommended for infants.
Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients

Carbomer, ethanolamine, polyethylene glycol, water USP.

Description

Ethyl Alcohol 70% v/v.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Product Label

Active Ingredient

Ethyl Alcohol 70% v/v.

Structured Label Content

Warnings

For external use only. Flammable. Keep away from heat or flame.

Do not use

in children less than 2 months of age

on open skin wounds



When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

Uses

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Purpose

Antiseptic

Directions
  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Adult supervision for children under 6 years of age when using this product to avoide swallowing.
  • Not recommended for infants.
Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients (Inactive ingredients)

Carbomer, ethanolamine, polyethylene glycol, water USP.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Product Label

Active Ingredient

Ethyl Alcohol 70% v/v.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:00:26.986291 · Updated: 2026-03-14T23:00:53.570671