Medichoice Hand Sanitizer
FDA Label NDC 55504-4000

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Donovan Industries, Inc. for the product Medichoice Hand Sanitizer (NDC 55504-4000). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Drug Facts

 Active Ingredients:                                      Purpose

Ethyl Alcohol 62 percent                             Antiseptic

Otc - Purpose

Use: For handwashing to decrease bacteria on skin.

Warnings

Warnings:

Flammable. Keep away from heat or flame.

For external use only.

Do not use in the eyes.

In case of deep or puncture wounds, consult doctor.

In rare instances of irritation, discontinue use if irritation and redness  develop.

If condition persists for more than 72 hours, consult a physician.

If swallowed, contact a physician or poison center.

Keep out of reach of children.


Dosage & Administration

Directions:

To decrease bacteria on skin, apply a small amount to palm.

Briskly rub covering hands with product until dry.

Inactive Ingredient

Inactive Ingredients: Water, Isopropyl Alcohol, Hydrogenated Starch, Carbomer, THP Ethylenediamine, and Fragrance.

Package Label.Principal Display Panel

MediChoice

Alcohol Gel

Hand Sanitizer


4 FL. OZ. 118ml


Medichoicehandsanitizer (Medichoice4oz)

Medichoicehandsanitizer (Medichoice4oz)

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