Label: SPAREDI MINT AND EUCALYPTUS MASK- benzalkonium chloride cream

  • 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 January 17, 2023

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  • ACTIVE INGREDIENT

    Benzalkonium chloride 0.1%

  • PURPOSE

    Antibacterial

  • USES:

    To decrease bacteria on the skin.

  • DIRECTIONS:

    Apply a thin layer to cover the foot. Leave for 10 minutes, then rinse
    thoroughly with warm water.

  • WARNINGS

    For external use only.

  • WHEN USING

    •Keep out of eyes. In case of contact with eyes, rinse thoroughly
    with water.• Do not apply to wounds or damaged skin.
    •Do not apply to the irritated skin or if excessive irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control Center right away.

  • INACTIVE INGREDIENT

    Aqua, Cetyl Alcohol, Stearyl Alcohol, Methyl Salicylate, Eucalyptus Globulus Leaf Oil, DMDM Hydantoin, Methylparaben, Propylparaben, Mentha Piperita (Peppermint) Oil, Sodium Hyaluronate, Sodium PCA, Wheat Amino Acids, Panthenol, Symphytum Officinale (Comfrey) Extract, Hydroxyproline, Cetrimonium Chloride, Argania Spinosa Kernel Oil (Organic), Cocos Nucifera Oil (Organic), FD&C Yellow #5 (CI 19140), FD&C Blue #1 (Cl 42090).

  • SPAREDI - MINT AND EUCALYPTUS CREAM MASK 0.7 oz

    MINT CREAM MASK 07

  • INGREDIENTS AND APPEARANCE
    SPAREDI MINT AND EUCALYPTUS MASK 
    benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49283-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    ARGANIA SPINOSA WHOLE (UNII: 83K6O4FR76)  
    EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    SODIUM COCOYL WHEAT AMINO ACIDS (UNII: JW3VT57I11)  
    HYDROXYPROLINE (UNII: RMB44WO89X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y)  
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49283-101-0720 g in 1 POUCH; Type 0: Not a Combination Product01/17/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/17/2023
    Labeler - CHEMCO CORPORATION (032495954)
    Registrant - CHEMCO CORPORATION (032495954)
    Establishment
    NameAddressID/FEIBusiness Operations
    CHEMCO CORPORATION032495954manufacture(49283-101)
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