Label: EMELY 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 December 31, 2021

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  • Active Ingredient(s)

    Alcohol 80% v/v Purpose: Antiseptic

  • Purpose

    Aseptic, Hand Sanitizer

  • Uses

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

  • Warnings

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

    Do not use

    in children less than 2 months of age

    on open skin wounds

  • WHEN USING

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

  • STOP USE

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

  • 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.

  • 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 15-30C (59-86F)

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

  • Inactive Ingredients

    Glicerin, Purified Water USP, Triethanolamine, Carbomer

  • Package Label - Principal Display Panel

    ​60 mL NDC: 77998-001-10 60 mL Gel

  • Package Label - Principal Display Panel

    120 mL NDC: 77998-001-20

    120 mL Gel

  • Package Label - Principal Display Panel

    240 mL NDC: 77998-001-30

    240 mL Gel

  • Package Label - Principal Display Panel

    480 mL NDC: 77998-001-40

    480 mL Gel

  • Package Label - Principal Display Panel

    960 mL NDC: 77998-001-50

    960 mL Gel

  • Package Label - Principal Display Panel

    1920 mL NDC: 77998-001-60

    1920 mL Gel

  • Package Label - Principal Display Panel

    3785 mL NDC: 77998-001-70

    3785 mL Gel

  • INGREDIENTS AND APPEARANCE
    EMELY HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77998-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77998-001-1060 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    2NDC:77998-001-20120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    3NDC:77998-001-30240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    4NDC:77998-001-40480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    5NDC:77998-001-50960 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    6NDC:77998-001-601920 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    7NDC:77998-001-703785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2020
    Labeler - Laboratorios E&M SRL (817468959)
    Establishment
    NameAddressID/FEIBusiness Operations
    Laboratorios E&M SRL817468959manufacture(77998-001) , analysis(77998-001) , pack(77998-001) , label(77998-001)
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