Hand Gel Sanitizer
FDA Label NDC 78851-333

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Allied Pressroom Products for the product Hand Gel Sanitizer (NDC 78851-333). 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 other, active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Other

→ Active Ingredient(s)

→ Purpose

→ Use

→ Warnings

→ Do Not Use

→ Otc - When Using

→ Otc - Stop Use

→ Otc - Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Package Label - Principal Display Panel

Other

This is an ethanol based hand sanitizer manufactured following the CDC recomendation of using an alcohol concentration of more than 60 % v/v alcohol when soap and water is not available.

It is manufactured by gelling a 70 % ethanol solution with the the minimum of an acrylate polymer to create a clear gel that is easy to apply and does not evaporate as readiliy as the liquid versions to provide sufficient dwell time to be effective.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product::

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.
Glycerin (1.00 % v/v)..
Polypropylene Glycol (1.2 % v/v)..
Acrylate Polymer (0.3% v/v).
Sterile distilled water or boiled cold water.

No other materials are used.

Active Ingredient(S)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

For external use only. Flammable. Keep away from heat or flame

Do Not Use

in children less than 2 months of age
on open skin wounds

Otc - When Using

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Stop Use

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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.

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.
Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

Store between 15-30C (59-86F)
Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

Water, Polypropylene Glycol, glycerin, Acrylate polymer.

Package Label - Principal Display Panel

3785 ml NDC 78851-333-05

946 ml NDC 78851-333-04

240 ml NDC 78851-333-03

120 ml NDC 78851-333-02

105 ml NDC 78851-333-01 back 105 ml NDC: 78851-333-01 front

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