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Retadolor (Concept Laboratories, Inc.)

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CREAM 85 g in 1 BOTTLE (64058-241-13) Label Information

Complete Retadolor Information

  • ACTIVE INGREDIENT

    Active ingredient Purpose
    Menthol 12% Pain Relieving
    Camphor 6% Pain Relieving

  • Uses

    for the temporary relief of minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • sprains
    • bruises

  • Warnings

    For external use only.

    • do not apply to wounds or damaged skin
    • do not bandage tightly

    When using this product do not get into eyes

    • avoid contact with other mucous membranes

    Flammable: Keep from heat and flame.

    Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children.

    • if swallowed, get medical help or contact a Poison Control center right away

    • if pregnant or nursing, seek the advice of a health professional before using

  • Directions

    • Apply liberally to affected area not more than 4 times daily unless otherwise directed by your physician or pharmacist
    • Gently massage into the skin until fully absorbed
    • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

  • Inactive ingredients

    Water (Aqua), Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Methane Carboximide, Methyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octrenylsuccinate, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate


  • SPL UNCLASSIFIED SECTION

    Exclusively manufactured for
    LaCar Sales & Marketing Inc.
    by Concept Laboratories, Inc.
    Chicago, IL 60642
    www.retadolor.com
    #CL9957


  • PRINCIPAL DISPLAY PANEL - 85g Bottle Label

    RETADOLOR
    NDC 64058-241-13
    The Anti-Pain

    PENETRATING COOL THERAPY CREAM

    Topical Analgesic for the Relief of
    TENSION, STRAINS, SPRAINS
    & MUSCLE PAIN

    Contains Powerful
    Menthol & Camphor
    with Vanishing
    Scent

    ANTI-INFLAMMATORY
    OMEGA
    3, 6 & 9
    with
    IcePearls

    NET WT. 3 OZ (85g)

    Principal Display Panel - 85g Bottle Label

  • INGREDIENTS AND APPEARANCE
    RETADOLOR   PENETRATING COOL THERAPY
    menthol and camphor (synthetic) cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:64058-241
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol 10.2 g  in 85 g
    Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic) 5.1 g  in 85 g
    Inactive Ingredients
    Ingredient Name Strength
    Water (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ALCOHOL (UNII: 3K9958V90M)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    ACAI OIL (UNII: Z0W6766A2W)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64058-241-13 85 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH FINAL part348 07/27/2009
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    Name Address ID/FEI Business Operations
    Concept Laboratories, Inc. 962282612 MANUFACTURE