Label: MEDI-HANDS- chloroxylenol soap

  • NDC Code(s): 68978-708-04
  • Packager: Topmost Chemical & Paper Corporation
  • 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 July 29, 2020

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  • Medi-Hands

    ​Active Ingredient

    Chloroxylenol 0.375%

  • Medi-Hands

    Uses

    • ​​Antibacterial hand cleaner.
    • Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics
  • Medi-Hands

    Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Children under the age of 6 should be supervised by an adult when using this product.
    • Discontinue use is irritation or redness develops.
    • If irritation persists for more than 72 hours, consult a physician.
    • KEEP OUT OF REACH OF CHILDREN.
  • Medi-Hands

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense 1-2 pumps of product onto wet palm.
    • Lather and rinse hands with clean water
  • Medi-Hands

    Inactive Ingredients

    ​Water, Sodium Lauryl lSulfate, Cocamide DEA, Cocamidopropyl betadine, Phenoxyethanol, Sodium Laureth Sulfate, Propylene Glycol, Fragrance, DMDM Hydantoin, Glycol Stearate, Laurimide DEA, Glycerine, Tocopheryl Acetate, D&C Green #5, FD&C Yellow #5.

  • Medi-Hands

    Purpose

    Antibacterial

  • Medi-Hands

    Medi-Hands

    KEEP OUT OF REACH OF CHILDREN

  • Medi-Hands Pearlized Antibacterial Skin Cleanser with PCMX Distributed by: TOPMOST CHEMICAL & PAPER CORP. 3394 Winchester Rd. Memphis, TN 38118 (901) 363-7278

    14104-00_Topmost_MediHands

    14104 Topmost MediHands

  • INGREDIENTS AND APPEARANCE
    MEDI-HANDS 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68978-708
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    LAURIC DIETHANOLAMIDE (UNII: I29I2VHG38)  
    LAURIC ISOPROPANOLAMIDE (UNII: 82DUX3RRVU)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    ETHYLENE OXIDE (UNII: JJH7GNN18P)  
    ETHYL METHYLPHENYLGLYCIDATE (UNII: UD51D5KR4A)  
    CHLOROACETIC ACID (UNII: 5GD84Y125G)  
    DIOXANE (UNII: J8A3S10O7S)  
    CALCIUM SILICATE (UNII: S4255P4G5M)  
    SODIUM FERROCYANIDE (UNII: 5HT6X21AID)  
    DIMETHYL BENZYL CARBINYL ACETATE (UNII: 6Y9488RL8H)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    ETHYL BUTYRATE (UNII: UFD2LZ005D)  
    MYRCENE (UNII: 3M39CZS25B)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    METHYL ANTHRANILATE (UNII: 981I0C1E5W)  
    SODIUM ALUMINIUM SILICATE (UNII: 058TS43PSM)  
    ETHYL ACETOACETATE (UNII: IZP61H3TB1)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    .GAMMA.-DECALACTONE (UNII: 7HLS05KP9O)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    DIMETHYL BENZYL CARBINYL BUTYRATE (UNII: 3Q0C60547R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68978-708-043780 mL in 1 JUG; Type 0: Not a Combination Product05/03/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/06/2014
    Labeler - Topmost Chemical & Paper Corporation (086944576)
    Registrant - Betco corporation, Ltd. (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corpo, Ltd.005050158manufacture(68978-708) , pack(68978-708) , label(68978-708)
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