KATE NATURALS ADVANCED HAND SANITIZER ORIGINAL- alcohol gel 
KATE NATURALS ADVANCED HAND SANITIZER 70%- alcohol gel 
THE DOJO 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 hand sanitizer is manufactured using the following ingredients:

Ethyl Alcohol (70%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.

Aloe Barbadensis Leaf

Carbomer

Glycerol

Triethanolamine

Active Ingredients(s)

Ethyl Alcohol 70% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand sanitizer to help reduce bacteria on the skin

Warnings

For external use only. Flammable. Keep away from heat or flame

When using this product, keep out of eyes, ears, and mouth.

In case of contact with eyes, rinse eyes throughly 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.

Directions

Other information

Store under 105F

Inactive ingredients

Water (Aqua), Glycerol, Aloe Barbadensis Leaf Juice, Carbomer, Triethanolamine

Package Level - Principal Display Panel

500ml NDC: 75498-170-16

Hand Sanitizer 500ml 70

Package Label - Principal Display Panel

237ml NDC: 75498-170-08

Hand Sanitizer 237ml 170-8

Package Label - Principal Display Panel

237ml NDC: 75498-175-08

Hand Sanitizer 8oz 175-8

Package Label - Principala Display Panel

500ml NDC: 75498-175-16

Hand Sanitizer 16oz 175-16

KATE NATURALS ADVANCED HAND SANITIZER ORIGINAL 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75498-175
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75498-175-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2020
2NDC:75498-175-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/09/2020
KATE NATURALS ADVANCED HAND SANITIZER 70% 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75498-170
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
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75498-170-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2020
2NDC:75498-170-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/09/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/09/2020
Labeler - THE DOJO LLC (030972745)
Establishment
NameAddressID/FEIBusiness Operations
THE DOJO LLC030972745repack(75498-175) , manufacture(75498-170)

Revised: 5/2020
Document Id: a532ea21-3c3a-3f2b-e053-2a95a90a67f2
Set id: a532ea21-3c39-3f2b-e053-2a95a90a67f2
Version: 1
Effective Time: 20200509
 
THE DOJO LLC