Label: GELMEX BLACK- 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 September 4, 2020

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  • Active Ingredient

    Alcohol 80%v/v

  • Purposes

    Antiseptic

  • Uses

    • Hand sanitizer to help reduce bacteria that potentially can cause disease.
    • For use when soap and water are not available.
  • Warnings

    For external use only. Flammable. Keep away from heat or flamme.

    Do not mix use with other household chemicals.

    Do not use

    • In children less than two months of age. 
    • On open skin wounds.

    When using this product:

    • Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes throughly with water. 

    Stop use and ask a doctor if irritation or rash occurs. These maybe sings of serious condition. 

  • Keep out of reach of children 

    If swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    • Place enough product on hands to cover all surfaces. Rub hands together untill dry. 
    • Supervise children under 6 years age when using this product to avoid swallowing.
  • undefined

    • Store between 15-30°C (59-86°F)
    • Avoid freezing and excesive heat above 400°C (104°F)
  • Inactive ingredients

    Glycerin, carbomer 940, aloe vera extract, purified water.

  • Image

    image description

  • INGREDIENTS AND APPEARANCE
    GELMEX BLACK 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80308-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80308-001-015 mL in 1 POUCH; Type 0: Not a Combination Product08/31/2020
    2NDC:80308-001-02250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2020
    3NDC:80308-001-03500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/31/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/31/2020
    Labeler - Grupo Siller Ingeniería Construcción y Materiales, S.A. de C.V (951577512)
    Establishment
    NameAddressID/FEIBusiness Operations
    Grupo Siller Ingeniería Construcción y Materiales, S.A. de C.V951577512manufacture(80308-001)
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