MEDIFECT HAND SANITIZER- alcohol liquid 
Medical Chemical Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MediFect Spray

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:

  1. 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.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. 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.

Warnings

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

handsanitizerspray

MEDIFECT HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:12745-901
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) HYDROGEN PEROXIDE4.17 mL  in 100 mL
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:12745-901-01237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/23/2020
2NDC:12745-901-02473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/23/2020
3NDC:12745-901-033785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Medical Chemical Corporation (008496861)
Registrant - Medical Chemical Corporation (008496861)
Establishment
NameAddressID/FEIBusiness Operations
Medical Chemical Corporation008496861manufacture(12745-901)

Revised: 1/2022
Document Id: d5cf542f-3012-392a-e053-2995a90ad6af
Set id: b3292ddb-cb95-7d5e-e053-2995a90a00d6
Version: 2
Effective Time: 20220117
 
Medical Chemical Corporation