Label: 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 June 10, 2020

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  • 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

    Directions

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

  • 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.

  • ACTIVE INGREDIENT

    Active ingredient. Ethyl Alcohol 70% v/v…

  • PURPOSE

    Purpose Antmicrobial

  • WARNINGS AND PRECAUTIONS

    Store below 110°F (43°C)

    Children under 6 years of age should be supervised when using.

  • WARNING

    Warnings

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

  • STOP USE

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

  • PACKAGE LABEL

    LABEL HAND SANITIZER 250 mLLABEL HAND SANITIZER 500 mLLABEL 1000 mL ENGLISH

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78814-6000
    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
    GLYCERIN (UNII: PDC6A3C0OX) 0.025 mL  in 1 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.01 mL  in 1 mL
    WATER (UNII: 059QF0KO0R) 0.205 mL  in 1 mL
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C) 0.06 mL  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78814-6000-1250 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
    2NDC:78814-6000-2500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
    3NDC:78814-6000-31000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/08/2020
    Labeler - FARMIRAL, S.A. DE C.V. (951579167)
    Registrant - FARMIRAL, S.A. DE C.V. (951579167)
    Establishment
    NameAddressID/FEIBusiness Operations
    FARMIRAL, S.A. DE C.V.951579167manufacture(78814-6000)
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