Label: GELRITE- hand sanitizer 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 January 13, 2022

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  • Active Ingredient

    Alcohol 65%

  • ​ Purpose

    Skin Protectant

  • ​Uses

    • For handwashing to decrease bacteria on skin.
    • Recommended for repeated use.
  • ​Warnings

    For external use only.

    ​Flammable. Keep away from heat and flame.

    Avoid contact with eyes. ​In case of contact, flush thoroughly with water.

    Stop use and ask a doctor if skin irritation develops.

    .

  • Directions

    • ​Wet hands thoroughly with product and allow to dry without wiping.
    • Children under six should be supervised while using this product.
  • Other Information

    • Do not store above 105°F
    • May discolor some fabrics or surfaces
    • You may report a serious adverse event to DermaRite Industries, PO Box 7209, North Bergen, NJ 07047
  • ​Inactive ingredients

    Water, Propylene Glycol, Carbomer, Polysorbate 20, Fragrance, t-Butanol, Triethanolamine, Tocopherol Acetate, Sodium Isostearoyl Lactate, Denatonium Benzoate

  • Questions?

    Call 1-800-337-6296 Mon-Fri 9AM-5PM EST.

  • Keep out of reach of children

    Keep out of reach of children. ​In case of accidental ingestion contact a physician or Poison Control Center right away

  • GelRite Package Label Principal Display Panel

    Principal Display Panel

  • INGREDIENTS AND APPEARANCE
    GELRITE 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61924-106
    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)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DENATONIUM BENZOATE ANHYDROUS (UNII: M5BA6GAF1O)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
    BUTANOL (MIXED ISOMERS) (UNII: WB09NY83YA)  
    2,4,5-T-TROLAMINE (UNII: 9007L1DAXM)  
    SODIUM ISOSTEAROYL LACTYLATE (UNII: 8730J0D3EV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61924-106-04118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product04/25/2006
    2NDC:61924-106-16473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product04/25/2006
    3NDC:61924-106-27800 mL in 1 BAG; Type 0: Not a Combination Product04/25/2006
    4NDC:61924-106-341000 mL in 1 BAG; Type 0: Not a Combination Product04/25/2006
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/25/2006
    Labeler - DERMARITE INDUSTRIES, LLC (883925562)
    Registrant - DERMARITE INDUSTRIES, LLC (883925562)
    Establishment
    NameAddressID/FEIBusiness Operations
    DERMARITE INDUSTRIES LLC883925562manufacture(61924-106)
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