Label: MEDIFENSE CLEAN HAND MIST GREENERY BOUQUET- alcohol spray

  • 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 19, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    ALCOHOL 70.0% v/v

  • Purpose

    ANTISEPTIC

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

  • Uses

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

  • Directions

    • For optimal results, place enough product on hands and rub hands together for 30 seconds.
    • 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

    1,2-Hexanediol, 3-O-Ethyl Ascorbic Acid, Benzyl Salicylate, Butylphenyl Methylpropional, Chamomilla Recutita (Matricaria) Flower Extract, Citric acid, Cymbopogon Schoenanthus Extract, Eugenol, Fragrance, Glycerin, Lavandula Angustifolia (Lavender) Flower Extract, Linalool, Panthenol, PEG-40 Hydrogenated Castor Oil, PEG-60 Hydrogenated Castor Oil, Rosmarinus Officinalis (Rosemary) Extract, Saccharide Isomerate, Salvia Officinalis (Sage) Leaf Extract, Sodium Citrate, Tocopheryl Acetate, Water

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of container

  • INGREDIENTS AND APPEARANCE
    MEDIFENSE CLEAN HAND MIST GREENERY BOUQUET 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74005-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL21 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    3-O-Ethyl Ascorbic Acid (UNII: 6MW60CB71P)  
    Benzyl Salicylate (UNII: WAO5MNK9TU)  
    Butylphenyl Methylpropional (UNII: T7540GJV69)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
    Eugenol (UNII: 3T8H1794QW)  
    Glycerin (UNII: PDC6A3C0OX)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Panthenol (UNII: WV9CM0O67Z)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    ROSEMARY (UNII: IJ67X351P9)  
    Saccharide Isomerate (UNII: W8K377W98I)  
    SAGE (UNII: 065C5D077J)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74005-040-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/01/2020
    Labeler - L&P Cosmetic Co., Ltd. (557821713)
    Registrant - L&P Cosmetic Co., Ltd. (557821713)
    Establishment
    NameAddressID/FEIBusiness Operations
    E.CIS COSMETIC.,Co.Ltd689846270manufacture(74005-040)