Label: SPATHERAPY- alcohol lotion

  • 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 March 3, 2014

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    Water, PEG-40 Hydrogenated Castor Oil, Acrylates/C10-30

    Alkyl Acrylate Crosspolymer, DMDM Hydantoin, Parfum,

    Sodium Hydroxide, Tocopherol Acetate,

    Simmondsia, Chinensis

    (Jojoba) Seed Wax,

    CI 19140, CI 14700

  • ACTIVE INGREDIENT

    Active Ingredient

    Alcohol Denat 60 % w/w

  • PURPOSE

    Purpose Antibacterial

  • INDICATIONS & USAGE

    Use - To decrease bacteria

    on the skin and clean hands - Recommended

    for repeated use

  • WARNINGS

    Warnings

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children. If accidentally

    swallowed, get medical help or contact a

    Poison Control Center right away.

  • OTHER SAFETY INFORMATION

    Do not get into eye. If contact

    occurs, rinse thoroughly with water.

  • STOP USE

    Discontinue use if irritation or redness

    develops. If irritation persists for more than

    72 hours, consult a doctor.

  • DOSAGE & ADMINISTRATION

    Directions - Apply to hands

    until thoroughly wet. Rub

    vigorously until dry.

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    SPATHERAPY  
    alcohol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53057-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL18 mL  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    SIMMONDSIA CHINENSIS SEED WAX (UNII: 47X6Y9FJJ2)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53057-005-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/15/2014
    Labeler - TRIZ LABORATORIES LTD (421290822)
    Establishment
    NameAddressID/FEIBusiness Operations
    TRIZ LABORATORIES LTD421290822manufacture(53057-005)
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