Label: DR. SAM PREMIUM HAND SANITIZER (500ML)- ethyl 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 2, 2020

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  • Active ingedient

    Ethanol (ethyl alcohol) (62%)

  • Purpose

    Antibacterial

  • Uses

    Hand sanitizer for decreasing bacteria on skin

  • Warnings

    For external use only

    Do not use if you are allergic to any of the ingredients

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. avoid contact with broken, irritated, or itching skin. Do not puncture or incinerate.

    Stop use and ask a doctor if irritation or redness develops and condition persists for more than 72 hours.

    If pregnant or breast-feeding, ask a health professional before use

  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • Directions

    Apply the adequate amount on hands

  • Inactive ingredients

    Purified water, Glycerin, L-menthol, Carbomer, Aminomethyl Propanol, Aloe extract

  • Dr. Sam Premium Hand Sanitizer (500mL)

    draft dr sam 500

  • INGREDIENTS AND APPEARANCE
    DR. SAM PREMIUM HAND SANITIZER (500ML) 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78012-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE (UNII: V5VD430YW9)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78012-101-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/25/2020
    Labeler - G.E.O MARKETING CORP (080740733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Korea Medicare Co.,Ltd.695832135manufacture(78012-101)
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