Label: CUBRE T 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 January 4, 2022

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  • Drug Facts

  • Active ingredient

    Ethyl alcohol 70%v/v

    Purpose

    Antimicrobial

  • Uses

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

    Flammable

    • Keep away from fire or flame.
    • For external use only.

    When using this product

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

    Stop use and ask a doctor

    if skin irritation occurs.

    Keep out of reach of children.

    If swallowed, get medical help in a Poison Control Center immediately.

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store below 110°F (43°C)
    • May discolor certain fabrics
  • Inactive Ingredients

    Triethannolamine, Carbomer, Polysorbate, Water, Glycerin.

  • Questions?

    +52 1 56 1876 7678 info@cubret.mx

  • Package Labeling:125ml

    Label

  • Package Labeling:250ml

    Label2

  • Package Labeling:500ml

    Label3

  • Package Labeling:1000ml

    Label4

  • INGREDIENTS AND APPEARANCE
    CUBRE T HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79410-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79410-000-0170 in 1 BOX06/01/2020
    1125 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:79410-000-0230 in 1 BOX06/01/2020
    2250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:79410-000-0320 in 1 BOX06/01/2020
    3500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:79410-000-0412 in 1 BOX06/01/2020
    41000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2020
    Labeler - Corporativo Cubrete, S.A. de C.V. (951579990)
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