KATE NATURALS ADVANCED HAND SANITIZER LEMONGRASS SCENT- alcohol gel KATE NATURALS ADVANCED HAND SANITIZER LAVENDER SCENT- alcohol gel

Kate Naturals Advanced Hand Sanitizer Lavender Scent by

Drug Labeling and Warnings

Kate Naturals Advanced Hand Sanitizer Lavender Scent by is a Otc medication manufactured, distributed, or labeled by THE DOJO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• in children less than 2 months of age
• on open skin wounds

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 persists.

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

• Place enough product on hands to cover all surfaces. Rub hands together until dry.
• Wet hands with product thoroughly, allow to dry without wiping.
• Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

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

500 mL NDC: NDC:

75498-375-16

500 mL NDC: NDC: 75498-375-16

INGREDIENTS AND APPEARANCE

KATE NATURALS ADVANCED HAND SANITIZER LEMONGRASS SCENT 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75498-275
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75498-275-16	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/12/2020

KATE NATURALS ADVANCED HAND SANITIZER LAVENDER SCENT 
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75498-375
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75498-375-16	500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	06/12/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/12/2020

Labeler - THE DOJO, LLC (030972745)

Establishment
Name	Address	ID/FEI	Business Operations
THE DOJO, LLC		030972745	manufacture(75498-275, 75498-375)