Label: CUBRETE ANTISEPTIC 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 July 8, 2020

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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 untill 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 INGREDIENT

    Inactive Ingredients Triethanolamine, Carbomer, Polysorbate, Water, Glycerin.

  • Questions?

    +52 1 56 1876 7678    info@cubret.mx

  • SPL UNCLASSIFIED SECTION

    Alcohol Based

    Manufactured by: Corporativo Cubrete, S.A. de C.V. Calzada las Aguilas 1709, Interior B, Lomas de Guadalupe, Alvaro Obregon, C.P.01720 Made in Mexio

    Imported by: Frozen Wheels, LLC 16565 NW 15th Ave. Miami, FL 33169

    HECHO EN

    MEXICO

  • Packaging

    untitled

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    CUBRETE ANTISEPTIC HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77031-105
    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
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77031-105-0250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
    2NDC:77031-105-04125 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
    3NDC:77031-105-08250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
    4NDC:77031-105-16500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
    5NDC:77031-105-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
    6NDC:77031-105-014000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/08/2020
    Labeler - Frozen Wheels, Llc (069055731)
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