LEAFREE HAND SANITIZER ALOE VERA 16.91OZ- ethyl alcohol gel 
LEAFREE HAND SANITIZER ALOE VERA 3.38 OZ- ethyl alcohol gel 
LEAFREE HAND SANITIZER ALOE VERA 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) (80%, 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 (0.24% v/v).
  3. Triethanolamine (0.2% v/v).
  4. Sterile distilled water or boiled cold water.
  5. ALOE VERA.

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)

Alcohol 70% v/v Alcohol 70% v/v. Purpose: ANTIMICROBIAL

Purpose

LabelAntiseptic, Hand Sanitizer

Use

LabelHand 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

Warnings:

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

Other information

Inactive ingredients

Carbomer, Triethanolamine, Aloe Vera, Water

Package Label - Principal Display Panel

100 mL NDC: 76573-160-18

300 ml NDC: 76573-370-05

500 ml NDC: 76573-530-09 500ml ALOE VERA300ml ALOE VERA100ml ALOE VERA

LEAFREE HAND SANITIZER ALOE VERA 16.91OZ 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76573-530
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
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 mL  in 100 mL
CARBOMER 1342 (UNII: 809Y72KV36) 0.24 mL  in 100 mL
CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E) 0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 29.06 mL  in 100 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76573-530-09500 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 finalpart333A03/30/2020
LEAFREE HAND SANITIZER ALOE VERA 3.38 OZ 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76573-160
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 1342 (UNII: 809Y72KV36) 0.24 mL  in 100 mL
CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E) 0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 29.06 mL  in 100 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 mL  in 100 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76573-160-18100 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 ALOE VERA 10.14OZ 
ethyl alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76573-370
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
ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.5 mL  in 100 mL
CARBOMER 1342 (UNII: 809Y72KV36) 0.24 mL  in 100 mL
CUPRIC TRIETHANOLAMINE (UNII: 6NU949U74E) 0.2 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 29.06 mL  in 100 mL
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76573-370-05300 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)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou Olande Cosmetic Co., Ltd529466827manufacture(76573-160, 76573-370, 76573-530)

Revised: 4/2020
Document Id: a4239aef-b6d6-a77d-e053-2995a90ac637
Set id: a3eaf9eb-a644-e33e-e053-2a95a90a6d14
Version: 3
Effective Time: 20200425
 
Corgiomed,LLC