WILDE ORCHID (ALCOHOL) GEL [TRIZ LABORATORIES LTD]

WILDE ORCHID (ALCOHOL) GEL [TRIZ LABORATORIES LTD]
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NDC 53057-012-01
Set ID e77ec618-d13f-4e21-9c01-d090a75b4c47
Category HUMAN OTC DRUG LABEL
Packager TRIZ LABORATORIES LTD
Generic Name
Product Class
Product Number
Application Number PART333E
  • 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,

    D and C Red 33 CI 17200, FD and C Red 4 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
    WILDE ORCHID  
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53057-012
    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)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53057-012-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/13/2014
    Labeler - TRIZ LABORATORIES LTD (421290822)
    Establishment
    NameAddressID/FEIBusiness Operations
    TRIZ LABORATORIES LTD421290822manufacture(53057-012)

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