SPL v1
SPL
SPL Set ID 549422db-8693-41f6-8312-7fb2ef40b0b7
Route
TOPICAL
Published
Effective Date 2020-07-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Alcohol (70 mL)
Inactive Ingredients
Water Glycerin Carbomer Homopolymer Type C (allyl Pentaerythritol Crosslinked) Trolamine Rosemary

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-20
Description

Ethyl Alcohol 70% v/v.

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Ethyl Alcohol 70% v/v.

Use

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

Section 50565-1

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

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 products 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

Directions
  • Place enough product on hands to cover all surfaces.. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Product Label

Active Ingredient

Ethyl Alcohol 70% v/v.

Other Information

Store above 15·30C (59·86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Carbomer, Glycerin, Purified Water, Rosmarinus Officinalis Extract, Triethanolamine

Structured Label Content

Use

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

Section 50565-1 (50565-1)

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

Purpose

Antiseptic

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 products 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

Directions
  • Place enough product on hands to cover all surfaces.. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.
Product Label (Product label)

Active Ingredient

Ethyl Alcohol 70% v/v.

Other Information (Other information)

Store above 15·30C (59·86F)

Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients (Inactive ingredients)

Carbomer, Glycerin, Purified Water, Rosmarinus Officinalis Extract, Triethanolamine

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:58:15.611974 · Updated: 2026-03-14T22:57:44.218849