576b7579-f44d-4315-a9c6-09d9a6d3f61d

SPL v2
SPL
SPL Set ID 576b7579-f44d-4315-a9c6-09d9a6d3f61d
Route
topical
Published
Effective Date 2023-11-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
alcohol (70 mL)
Inactive Ingredients
propylene glycol polyethylene glycol, unspecified water rapidgel ez1

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-11-30

Purpose

Antiseptic

Description

Ethanol 70% v/v. 


Medication Information

Warnings

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

Purpose

Antiseptic

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.
Other Information
  • Store between 15-30 oC (59-86 oF)
  • Avoid freezing and excessive heat above 40 oC (104 oF)
Inactive Ingredients

Propylene glycol, polyethylene glycol, acrylate polymer, distilled water, fragrance

Description

Ethanol 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.

Section 50567-7

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 ifirritation or rash occurs. These may be signs of a serious condition.

Do Not Use
  • in children less than 2 months of age
  • on open skin wounds
Product Label
Active Ingredient

Ethanol 70% v/v. 

Stop Use and Ask A Doctor

If irritation or rash occurs, These may be signs of a serious condition


Structured Label Content

Warnings

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

Purpose

Antiseptic

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.
Other Information (Other information)
  • Store between 15-30 oC (59-86 oF)
  • Avoid freezing and excessive heat above 40 oC (104 oF)
Inactive Ingredients (Inactive ingredients)

Propylene glycol, polyethylene glycol, acrylate polymer, distilled water, fragrance

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.

Section 50567-7 (50567-7)

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 ifirritation or rash occurs. These may be signs of a serious condition.

Do Not Use (Do not use)
  • in children less than 2 months of age
  • on open skin wounds
Product Label (Product label)
Active Ingredient

Ethanol 70% v/v. 

Stop Use and Ask A Doctor (Stop use and ask a doctor)

If irritation or rash occurs, These may be signs of a serious condition


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)