LEAFREE HAND SANITIZER 16.91OZ- ethyl alcohol gel LEAFREE HAND SANITIZER 3.38OZ- ethyl alcohol gel LEAFREE HAND SANITIZER 10.14OZ- ethyl alcohol gel

Leafree Hand Sanitizer 10.14oz by

Drug Labeling and Warnings

Leafree Hand Sanitizer 10.14oz by is a Otc medication manufactured, distributed, or labeled by Corgiomed,LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

1. 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.
2. Carbomer
3. Trolamine
4. 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

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.

STOP USE

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

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

INGREDIENTS AND APPEARANCE

LEAFREE HAND SANITIZER 16.91OZ 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76573-550
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 980 (UNII: 4Q93RCW27E)	0.24 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	29.56 mL  in 100 mL

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76573-550-09	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/28/2020

LEAFREE HAND SANITIZER 3.38OZ 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76573-170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 980 (UNII: 4Q93RCW27E)	0.24 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	29.56 mL  in 100 mL

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76573-170-19	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

LEAFREE HAND SANITIZER 10.14OZ 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76573-390
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER 980 (UNII: 4Q93RCW27E)	0.24 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	29.56 mL  in 100 mL

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76573-390-16	300 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/30/2020

Labeler - Corgiomed,LLC (117502701)

Registrant - Corgiomed,LLC (117502701)