Label: DICOLOR- 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 November 4, 2020

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  • DIRECTIONS DOSAGE AND ADMINISTRATION

    Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.

  • INACTIVE INGREDIENTS

    Inactive ingredients Water (Aqua), Glycerin, Carbomer, Triethanolamine

  • INDICATIONS AND USAGE

    Use[s]

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • PURPOSE

    Purpose Antmicrobial

  • WARNINGS AND PRECAUTIONS

    Store below 110°F (43°C)

    Avoid freezing and excessive heat above 40C (104F)

    Supervise children under 6 years of age when using this product to avoid swallowing.

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • WARNINGS

    Warnings

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

  • ACTIVE INGREDIENT

    Active ingredient Ethyl Alcohol 70% v/v

  • ASK A DOCTOR

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • PACKAGE LABELS

    DI COLOR HAND SANITIZER GEL

  • INGREDIENTS AND APPEARANCE
    DICOLOR 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79050-0040
    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
    WATER (UNII: 059QF0KO0R) 0.248 mL  in 1 mL
    AMMONIA (UNII: 5138Q19F1X) 0.007 mL  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.02 mL  in 1 mL
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.025 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79050-0040-61000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/17/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/17/2020
    Labeler - SODI PINTURAS, S.A. DE C.V. (951579471)
    Registrant - SODI PINTURAS, S.A. DE C.V. (951579471)
    Establishment
    NameAddressID/FEIBusiness Operations
    SODI PINTURAS, S.A. DE C.V.951579471manufacture(79050-0040)
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