Santi-gel Instant Hand Sanitizer Solution
FDA Label NDC 50865-056

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kutol Products Company, Inc. for the product Santi-gel Instant Hand Sanitizer (NDC 50865-056). 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 warnings, otc - active ingredient, otc - keep out of reach of children, inactive ingredient, dosage & administration, otc - purpose, indications & usage, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Warnings

Flammable. Keep away from heat or flame.

For external use only.

Do not use in the eyes. In case of contact, immediately flush 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 - Active Ingredient

Ethyl Alcohol 62% v/v.........Antibacterial Agent

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. 

Inactive Ingredient

Water, Glycerin, Propylene Glycol, Isopropyl Mryistate, Aloe Barbadensis leaf, Tocopheryl Acetate (Vitamin E), Carbomer, Aminomethyl Propanol

Dosage & Administration

To decrease bacteria on skin, apply a small amount to palm. Briskly rub, covering hands with product until dry.

Children under 6 years of age should be supervised when using this product.

Otc - Purpose

Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Indications & Usage

Hand Sanitizer to help reduce bacteria on the skin that could cause disease. Recommended for repeated use.

Do not use in the eyes. In case of contact, immediately flush 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.

Package Label.Principal Display Panel

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50865-056-65.jpg (50865 056 65)

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