FDA Label for Medifect Hand Sanitizer
View Indications, Usage & Precautions
Medifect Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Medical Chemical Corporation. 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. Hydrogen peroxide, 0.13% w/v. Purpose: Antiseptic
Purpose
Antiseptic
Use
Uses: Intended for use as a hand sanitizer spray.
Warnings
Danger: Highly flammable liquid and vapor. Keep away from heat, sparks, open flames, and hot surfaces. No smoking. Keep container tightly closed. Use only non-sparking tools. Take precautions against static discharge. Wear protective clothes and eye protection. In case of fire, use fire extinguishers approved for alcohol fires. In case of ingestion, contact a poison control center. Discontinue use if irritation or redness develops. Keep out of reach of children.
Keep out of reach of children.
Directions
Spray about 5 g (1 tsp.) on to one hand and spread over both hands to the wrist. Rub into the skin until dry. Repeat.
Other Information
Keep tightly closed and protected from light. Store at room temperature. Conforms to World Health Organization formula for spary hand sanitizers.
Inactive Ingredients
glycerin, purified water
Package Label - Principal Display Panel
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