Label: JIT HAND SANITIZERS- 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 April 8, 2020

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredients: ALCOHOL 62.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Water, Glycerin, Butylene Glycol, Aloe Barbadensis Leaf Extract, Carbomer, Triethanolamine, Flavor

  • PURPOSE

    Purpose: SANITIZER

  • WARNINGS

    Warnings:

    Flammable. Keep away from fire or flame.
    For external use only.

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

    Discontinue use if
    irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

  • 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.

  • Uses

    Uses:
    Hand sanitizer to help reduce bacteria on the skin.

  • Directions

    Directions:
    Put enough product in your palm to cover hands and rub hands together briskly until dry.
    Children under 6 years of age should be supervised when using this product.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    JIT HAND SANITIZERS 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50555-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL37.2 g  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50555-050-021 in 1 CARTON03/01/2020
    1NDC:50555-050-0160 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/01/2020
    Labeler - KMPHARMACEUTICAL Co.,Ltd. (688679158)
    Registrant - KMPHARMACEUTICAL Co.,Ltd. (688679158)
    Establishment
    NameAddressID/FEIBusiness Operations
    KMPHARMACEUTICAL Co.,Ltd.688679158manufacture(50555-050)
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!