Label: AISLINN HAND SANITIZER GEL- 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 July 28, 2020

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

  • ACTIVE INGREDIENT

    Ethyl alcohol 70% v/v

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    Hand Sanitizer to help reduce bacteria that potentially can cause disease
    Recommended for repeated use

  • WARNINGS

    For external use only.

    Flammable. Keep away from fire or flame.

  • WHEN USING

    When using this product keep out of eyes.

    In case of contact with eyes, flush thoroughly with water

    Avoid contact on broken skin. Do not inhale or ingest.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs.

    Condition persists for more than 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 hand thoroughly with product and rub into skin until dry.

    Children under 6 years of age should be supervised when using this product.

  • OTHER SAFETY INFORMATION

    Store between 15-30ºC (59-89ºF)

    Avoid freezing and excessive heating 40ºC (104ºF)

  • INACTIVE INGREDIENT

    Carbomer 940, Glycerin, Triethanolamine and Water

  • PRINCIPAL DISPLAY PANEL

    NDC 79664-100-01 500mL

    Hand Sanitizer 500mL

    NDC 79664-100-02 1000mL

    Hand Sanitizer 1000mL

    NDC 79664-100-03 4000mL

    Hand Sanitizer 4000mL

    NDC 79664-100-04 20000mL

    Hand Sanitizer 20000mL

    NDC 79664-100-05 200000mL

    Hand Sanitizer 200000mL

  • INGREDIENTS AND APPEARANCE
    AISLINN HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79664-100
    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
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79664-100-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product07/28/2020
    2NDC:79664-100-021000 mL in 1 BOTTLE; Type 0: Not a Combination Product07/28/2020
    3NDC:79664-100-034000 mL in 1 JUG; Type 0: Not a Combination Product07/28/2020
    4NDC:79664-100-0420000 mL in 1 CANISTER; Type 0: Not a Combination Product07/28/2020
    5NDC:79664-100-05200000 mL in 1 CYLINDER; Type 0: Not a Combination Product07/28/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/28/2020
    Labeler - Alcaraz Silva, Hector Alberto Tonathiú (951580213)