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 Tekna Fill, Inc.. 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.
Other
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Active Ingredient(S)
Alcohol 80% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Sanitizer to help reduce bacteria on the skin that could cause disease. Recommeded for repeated use
Warnings
Flammable. Keep away from fire or flame. For external use only.
Do Not Use
- for children less than 2 months of age
- on open skin wounds.
Otc - When Using
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts.
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 appears and lasts
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 in your palm to thoroughly cover your hands.
- Rub hands together briskly until dry.
- Children under 6 years of age should be supervised when using this product
Other Information
- Store below 110 oF (43 oC)
- May discolor certain fabrics or surfaces
Inactive Ingredients
Glycerin, hydrogen peroxide, purified water USP
Recent Major Changes
Warnings:
Flammable. Keep away from fire or flame.
For external use only
When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash appears and lasts
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Uses:
- Sanitizer to help reduce bacteria on the skin that could cause diease
- Recommended for repeated use
- Place enough product in your palm to thoroughly cover your hands
- Rub hands together briskly unitl dry
- Children under 6 years of age should be supervised when using this product
Directions:
Package Label - Principal Display Panel
18900 mL NDC: 77183-5195-0
18900mL in ONE PAIL
* Please review the disclaimer below.