FDA Label for Hand Sanitizer
View Indications, Usage & Precautions
Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Gentell. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient(S)
Isopropyl Alcohol 75% v/v. Purpose: Antiseptic
Purpose
Antiseptic
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
Do not use if you are allergic to any ingredients. For external use only. Flammable. Keep away from heat or flame
Do Not Use
in children less than 2 months of age or on open skin wounds
Otc - When Using
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.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
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
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