Spray Hand Sanitizer

Spray Hand Sanitizer
SPL v3
SPL
SPL Set ID a52829e8-a380-d383-e053-2995a90a7334
Route
TOPICAL
Published
Effective Date 2020-03-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Isopropyl Alcohol (1.45 mL)
Inactive Ingredients
Glycerin Hydrogen Peroxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-05-08

Description

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

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 50566-9

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

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

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

Warnings

Do not use if you are allergic to any ingredients. For external use only. Flammable. Keep away from heat or flame

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.
Do Not Use

in children less than 2 months of age or on open skin wounds

Other Information
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients

glycerin, hydrogen peroxide, purified water USP

Package Label Principal Display Panel

Gentell We make it better

Spray Hand Sanitizer

Isopropyl Alcohol Antiseptic 75%

Topical Solution

Non-Sterile Solution

2 oz 68 mL

GEN-41020

Gentell

2701 Bartram Road

Bristol, PA 19007

215-788-2700

FAX: 215-788-2715

www.gentell.com

Rev. April 2020


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.

Section 50566-9 (50566-9)

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

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

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

Purpose

Antiseptic

Warnings

Do not use if you are allergic to any ingredients. For external use only. Flammable. Keep away from heat or flame

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.
Do Not Use (Do not use)

in children less than 2 months of age or on open skin wounds

Other Information (Other information)
  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)
Active Ingredient(s)

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Inactive Ingredients (Inactive ingredients)

glycerin, hydrogen peroxide, purified water USP

Package Label Principal Display Panel (Package Label - Principal Display Panel)

Gentell We make it better

Spray Hand Sanitizer

Isopropyl Alcohol Antiseptic 75%

Topical Solution

Non-Sterile Solution

2 oz 68 mL

GEN-41020

Gentell

2701 Bartram Road

Bristol, PA 19007

215-788-2700

FAX: 215-788-2715

www.gentell.com

Rev. April 2020


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Raw Label Data

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