Label: KATE NATURALS ADVANCED HAND SANITIZER ORIGINAL- alcohol gel
KATE NATURALS ADVANCED HAND SANITIZER 70%- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated May 9, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    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

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

    In case of contact with eyes, rinse eyes throughly with water.

  • STOP USE

    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

    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

  • 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

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!