Label: CUIR 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 February 25, 2022

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  • DRUG FACTS

  • Active ingredient

    Alcohol 80% v/v

    Purpose

    Antiseptic

  • Uses

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

  • Warnings

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

    Do not use

    • In chilren less than 2 months of age
    • On open skin wounds

    When using this producto

    keep out of eyes, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask to a doctor

    if irritation or rash occurs. These may be signs of serious condition.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

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

    • Store between 15-30° C (59-86° F)
    • Avoid freezing and excessive heat above 40°C (104° F)
  • Inactive ingredients

    glycerine, hydregen peroxide, purifed water UPS.

  • Package Labeling:(78514-000-33)

    Bottle

  • Package Labeling:(78514-000-16)

    Bottle2

  • INGREDIENTS AND APPEARANCE
    CUIR HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78514-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.8 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78514-000-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    2NDC:78514-000-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/02/2020
    Labeler - Comercial Riley S.A. de C.V. (951578468)
    Establishment
    NameAddressID/FEIBusiness Operations
    Comercial Riley S.A. de C.V.951578468manufacture(78514-000)
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