Label: HAND SANITIZER- ethyl 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 December 10, 2017

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient:
    Ethyl Alcohol 62% w/w

  • PURPOSE

    Purpose

    Antiseptic

  • WARNINGS

    Warnings

    Flammable, keep away from fire or flame.

    For external use only.

  • STOP USE

    Stop use and ask a doctor if irritation and redness develops and persists for more that 72 hours.

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions

    • Wet hands thoroughly with product
    • Briskly rub hands together until dry
    • Supervise children in the use of this product

  • INACTIVE INGREDIENT

    Inactive Ingredients

    water, carbomer, fragrance, triethanoamine, glycerin, propylene glycol, isopropyl alcohol, isopropyl myristate, tocopheryl acetate, aloe vera extract

  • OTHER SAFETY INFORMATION

    Other Information

    • Store at room temperature 15 to 30C (59 to 86F)
    • May discolor certain fabrics

  • INDICATIONS & USAGE

    Use

    For hand washing to decrease bacteria on the skin

  • DO NOT USE

    Do not use in the eyes. In case of contact, rinse eyes thoroughly with water.

  • PRINCIPAL DISPLAY PANEL

    image of blister cardimage of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71927-001
    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
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71927-001-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product12/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E12/11/2017
    Labeler - Orazen Inc (080916640)
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!