Hand Sanitizer
FDA Label NDC 72686-189

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fareva Morton Grove, Inc. for the product Hand Sanitizer (NDC 72686-189). 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 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.

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (77%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
WATER (AQUA)
c. GLYCERIN
d. FRAGRANCE (PARFUM)
e. ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
f. MANNITOL
g. ALOE BARBADENSIS LEAF JUICE
h. AMINOMETHYL PROPANOL
i. MICROCRYSTALLINE CELLULOSE
j. TOCOPHERYL ACETATE
k. CHROMIUM HYDROXIDE GREEN (CI 77289)
l. HYDROXYPROPYL METHYLCELLULOSE
m. CITRIC ACID
n. SODIUM BENZOATE
o. POTASSIUM SORBATE

Active Ingredient(S)

Alcohol 77% v/v. Purpose: Antiseptic

Purpose

Antiseptic

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 and redness develops and persists.

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 and redness develops and persists.

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

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALOE BARBADENSIS LEAF JUICE, AMINOMETHYL PROPANOL, CHROMIUM HYDROXIDE GREEN (CI 77289), CITRIC ACID, FRAGRANCE (PARFUM), GLYCERIN, HYDROXYPROPYL METHYLCELLULOSE, MANNITOL, MICROCRYSTALLINE CELLULOSE, POTASSIUM SORBATE, SODIUM BENZOATE, TOCOPHERYL ACETATE, WATER (AQUA).

Package Label - Principal Display Panel

50 mL NDC: 72686-189-05

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