Leafree Hand Sanitizer With Aloe Vera 10.14oz
FDA Label NDC 76573-821

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Corgiomed,llc for the product Leafree Hand Sanitizer With Aloe Vera 10.14oz (NDC 76573-821). 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, warnings:, 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

→ Warnings:

→ 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.

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:

Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (70%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
Carbomer
Trolamine
Aloe Vera
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)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Uses:
Hand Sanitizer, reduce bacteria on the skin
Recommend for repeated use

Warnings

For external use only
Flammable, keep away from heat, fire or flame

Warnings:

Do not use Children less than 2 months of age on open skin wounds
Keep out of reach of children. If swallowed, get medical help or contact a poison Central right away

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

Directions:
Place enough product on hands to cover all surfaces. Rub hands together until dry.
Use as needed. No need to rinse with water
For children under 6 years of age, use only under adult supervision.
Not recommender for infants

Other Information

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

Inactive Ingredients

CARBOMER, TROLAMINE, ALOE VERA, WATER.

Package Label - Principal Display Panel

100 mL NDC:76573-820-10

300 ml NDC: 76573-821-11

500 ml NDC: 76573-822-12

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