Label: ESSENTIALS, M.D. HAND SANITIZER- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 30, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v.

  • Purpose

    Antimicrobial

  • Uses

    Hand Sanitizer to help reduce bacteria that potentially can cause disease.

    Reccomended for repeated use.

  • Warnings

    Flammable. Keep away from heat or flame.

    For external use only.

    When using this product do not use in or near the eyes. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • 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 thoroughly cover your hands. Rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using this product.

    Other information

    • Store below 110 F (43C).
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water, Isopropyl alcohol, Carbomer, Glycerin, Aminomethy Propanol.

  • Product Label

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  • INGREDIENTS AND APPEARANCE
    ESSENTIALS, M.D. HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77205-002
    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
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77205-002-011500 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    2NDC:77205-002-025000 mL in 1 BOTTLE; Type 0: Not a Combination Product06/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/30/2020
    Labeler - ALLEN-MEYER GROUP LLC (117509579)
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