Label: ASSURED INSTANT HAND SANITIZER- 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 June 2, 2020

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

View All Sections
  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 65% 

  • Purpose

     Antiseptic

  • Use

    • Hand sanitizer to help decrease bacteria on the skin  
    • when water, soap & towel are not available
    • Recommended for repeated use.
  • Warnings

    For external use only.

    Flammable,

    Keep away from fire or flame

    Do not apply around eyes, do not use in ears and mouth.

    When using this product

    avoid contact with eyes. In case of contact, rinse eyes with water immediately

    Stop use and ask a doctor if

    redness or irritation develop and persist for more than 72 hours

    Keep out of reach of children.

    Children must be supervised in use of this product.

  • Directions

    • Pump as needed into your palms and thoroughly spread on both hands
    • Rub into skin until dry.
  • Inactive ingredients

    Water, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Fragrance

  • SPL UNCLASSIFIED SECTION

    Other information

    • Store between 68-77℉ (20-25℃)
    • May discolor fabrics.
  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    ASSURED INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78524-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78524-002-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/02/2020
    Labeler - Gianthope Arts Product (Huizhou) Company Limited (529306767)
    Establishment
    NameAddressID/FEIBusiness Operations
    Gianthope Arts Product (Huizhou) Company Limited529306767manufacture(78524-002)
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!