LEAFREE HAND SANITIZER 16.91OZ- ethyl alcohol gel 
LEAFREE HAND SANITIZER 3.38OZ- ethyl alcohol gel 
LEAFREE HAND SANITIZER 10.14OZ- ethyl alcohol gel 
Corgiomed,LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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)

activeEthyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer 500ML

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:

500mlDo 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 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 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.

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

Inactive ingredients

CARBOMER, TROLAMINE, WATER.

Package Label - Principal Display Panel

500ML300ML100ML100 mL NDC:76573-170-19

300 ml NDC: 76573-390-16

500 ml NDC: 76573-550-09

LEAFREE HAND SANITIZER 16.91OZ 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76573-550
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76573-550-09500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/28/2020
LEAFREE HAND SANITIZER 3.38OZ 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76573-170
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76573-170-19100 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
LEAFREE HAND SANITIZER 10.14OZ 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76573-390
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76573-390-16300 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Corgiomed,LLC (117502701)
Registrant - Corgiomed,LLC (117502701)

Revised: 4/2020
Document Id: a42ef5a0-da97-643a-e053-2995a90ac3de
Set id: a42ecc76-ddbe-b074-e053-2a95a90ae9a2
Version: 4
Effective Time: 20200426
 
Corgiomed,LLC