KATE NATURALS ADVANCED HAND SANITIZER LEMONGRASS SCENT- alcohol gel 
KATE NATURALS ADVANCED HAND SANITIZER LAVENDER SCENT- 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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The hand sanitizer is manufactured using the following ingredients:

  1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (75%, 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. Glycerine
  3. Trolamine
  4. Sterile distilled water or boiled cold water.
  5. Acrylic Acid/Sodium Acrylate Copolymer (1:1; 600 MPA.S at 0.2%)
  6. Lemongrass Oil

Active Ingredient(s)

Alcohol 75% v/v. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand 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

Do not use

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 persists.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

glycerin, trolamine, acrylic acid/sodiu, acrylate copolymer (1:1; 600 MPA.S at 0.2%), water, lemongrass oil

Package Label - Principal Display Panel

500 mL NDC: NDC 75498-275-16

Lemongrass

500 mL NDC: NDC 75498-375-16

500 mL NDC: NDC 75498-375-16

Lavender

KATE NATURALS ADVANCED HAND SANITIZER LEMONGRASS SCENT 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75498-275
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
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75498-275-16500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/12/2020
KATE NATURALS ADVANCED HAND SANITIZER LAVENDER SCENT 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75498-375
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
GLYCERIN (UNII: PDC6A3C0OX)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%) (UNII: M4PPW69Y4H)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75498-375-16500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/12/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/12/2020
Labeler - THE DOJO, LLC (030972745)
Establishment
NameAddressID/FEIBusiness Operations
THE DOJO, LLC030972745manufacture(75498-275, 75498-375)

Revised: 6/2020
Document Id: a7eb0730-3b07-b228-e053-2a95a90aa404
Set id: a7eb0730-3b07-b228-e053-2a95a90aa404
Version: 1
Effective Time: 20200612
 
THE DOJO, LLC