Label: HAND SANITIZING GEL- instant hand sanitizing gel gel

  • NDC Code(s): 61307-056-31
  • Packager: US Chemical Corporation
  • 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 August 24, 2023

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

View All Sections
  • DOSAGE & ADMINISTRATION

    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.

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, Glycerin, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol.

  • INDICATIONS & USAGE

    Uses Hand sanitizer to help reduce bacteria on the skin that could cause disease, Recommended for repeated use.

  • ACTIVE INGREDIENT

    Active Ingredient Ethyl Alcohol 62% v/v

  • 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.

  • PURPOSE

    Purpose Antibacterial Agent

  • WARNINGS

    Warnings Flammable. Keep away from fire or flame. For external use only. Avoid contact with eyes. In case of contact, flush with plenty of water. Stop and ask a doctor if irritation or rash appears and persists.

  • PRINCIPAL DISPLAY PANEL

    Principal LabelPrincipal Dispaly

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZING GEL 
    instant hand sanitizing gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61307-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61307-056-311500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/07/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/07/2013
    Labeler - US Chemical Corporation (031457842)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(61307-056)
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!