Label: INSTANT HAND SANITIZER- alcohol gel

  • NDC Code(s): 10565-076-02, 10565-076-04, 10565-076-08, 10565-076-16
  • Packager: Hydrox Laboratories
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to help reduce bacteria on the skin that could cause disease
  • Warnings

    Flammable. Keep away from fire or flame

    For external use only - hands.

    When using this productdo not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a physician ifskin irritation or rash develops.

    Keep out of reach of children.If accidently ingested, seek medical help or contact a Poison Control Center immediately.

  • Directions

    • place enough product in your palm to thoroughly cover your hands
    • rub hands together briskly until dry
    • children under 6 years of age should be supervised when using this product
  • Other Information

    • store at normal room temperature
    • may discolor certain fabrics
    • may be harmful to wood finishes and plastics
  • Inactive ingredients

    carbomer, fragrance, glycerin, isopropyl alcohol, isopropyl myristate, propylene glycol, purified water, tocopheryl acetate, aloe vera gel, AMP-95

  • SPL UNCLASSIFIED SECTION

    MFG BY: HYDROX LABORATORIES
    825 Tollgate Road ELGIN, IL 60123

  • PRINCIPAL DISPLAY PANEL 

    NDC 10565-076-04

    Hydrox
    Laboratories

    INSTANT
    HAND
    SANITIZER
    with moisturizers
    aloe & vitamin E

    KILLS 99.9%
    OF GERMS*

    4 FL OZ 118 mL

    Made in USA Principal Display Panel - 59 mL Cylinder Label

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10565-076
    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
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10565-076-0259 mL in 1 CYLINDER; Type 0: Not a Combination Product01/09/2012
    2NDC:10565-076-04118 mL in 1 CYLINDER; Type 0: Not a Combination Product01/09/2012
    3NDC:10565-076-08237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/09/2012
    4NDC:10565-076-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/09/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)01/09/2012
    Labeler - Hydrox Laboratories (025164302)
    Registrant - Hydrox Laboratories (025164302)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hydrox Laboratories025164302manufacture(10565-076) , label(10565-076) , pack(10565-076)
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!