FDA Label for Leafree Hand Sanitizer 16.91oz
View Indications, Usage & Precautions
Leafree Hand Sanitizer 16.91oz Product Label
The following document was submitted to the FDA by the labeler of this product Corgiomed,llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
- 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, WATER.
Package Label - Principal Display Panel
100 mL NDC:76573-170-19
300 ml NDC: 76573-390-16
500 ml NDC: 76573-550-09
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