OTC Medication Information: Kate Naturals Advanced Hand Sanitizer Original

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.

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

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product.

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
(click image for full-size original)

Package Label — Principal Display Panel

237ml NDC: 75498-170-08

Hand Sanitizer 237ml 170-8
(click image for full-size original)

Package Label — Principal Display Panel

237ml NDC: 75498-175-08

Hand Sanitizer 8oz 175-8
(click image for full-size original)

Package Label — Principala Display Panel

500ml NDC: 75498-175-16

Hand Sanitizer 16oz 175-16
(click image for full-size original)
KATE NATURALS ADVANCED HAND SANITIZER ORIGINAL
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75498-175
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 75 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
ACRYLIC ACID/SODIUM ACRYLATE COPOLYMER (1:1; 600 MPA.S AT 0.2%)
GLYCERIN
TROLAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75498-175-08 237 mL in 1 BOTTLE None
2 NDC:75498-175-16 500 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/09/2020
KATE NATURALS ADVANCED HAND SANITIZER 70%
alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:75498-170
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 70 mL in 100 mL
Inactive Ingredients
Ingredient Name Strength
TROLAMINE
GLYCERIN
WATER
ALOE VERA LEAF
CARBOMER 940
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75498-170-16 500 mL in 1 BOTTLE None
2 NDC:75498-170-08 237 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 05/09/2020
Labeler — THE DOJO LLC (030972745)
Establishment
Name Address ID/FEI Operations
THE DOJO LLC 030972745 repack (75498-175), manufacture (75498-170)

Revised: 05/2020 THE DOJO LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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