MediFect Spray

Manufacturer
Medical Chemical Corporation
Effective date
2022-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:07

Label at a glance#

ProductMediFect Hand Sanitizer
Active ingredientHYDROGEN PEROXIDE, ALCOHOL
Label structure10 sections

Dosage and administration

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.

Storage and handling

Keep tightly closed and protected from light. Store at room temperature. Conforms to World Health Organization formula for spary hand sanitizers.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

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)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Hydrogen peroxide, 0.13% w/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

Uses: Intended for use as a hand sanitizer spray.

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Keep tightly closed and protected from light. Store at room temperature. Conforms to World Health Organization formula for spary hand sanitizers.

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, purified water

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

handsanitizersprayhandsanitizerspray

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
12745-901-012024-01-30C16284748780-11030e365-525e-111a-e063-dadaa90a10e2MediFect Spray
12745-901-022024-01-30C16284748780-11030e365-525e-111a-e063-dadaa90a10e2MediFect Spray
12745-901-032024-01-30C16284748780-11030e365-525e-111a-e063-dadaa90a10e2MediFect Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
12745-901-01MediFect Hand Sanitizer237 mL in 1 BOTTLE, PLASTICLIQUID2372
12745-901-02MediFect Hand Sanitizer473 mL in 1 BOTTLE, PLASTICLIQUID4732
12745-901-03MediFect Hand Sanitizer3785 mL in 1 BOTTLE, PLASTICLIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
12745-901MEDIFECT HAND SANITIZER (ALCOHOL) LIQUID [MEDICAL CHEMICAL CORPORATION]2Legacy NDC, 3 package rows20220118_b3292ddb-cb95-7d5e-e053-2995a90a00d6.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12745-90112745-901-01, 12745-901-02, 12745-901-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d5cf542f-3012-392a-e053-2995a90ad6afb3292ddb-cb95-7d5e-e053-2995a90a00d62022-01-17WarningsExact identifier
spl id: d5cf542f-3012-392a-e053-2995a90ad6af
spl set id: b3292ddb-cb95-7d5e-e053-2995a90a00d6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.