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Mediflex (SAS Group Inc.)

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CREAM 85 g in 1 JAR (67662-001-03) Label Information

Complete Mediflex Information

  • ACTIVE INGREDIENT

    Menthol 5%


  • PURPOSE

    Topical Analgesic


  • INDICATIONS & USAGE

    For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.


  • WARNINGS

    For external use only.


  • DO NOT USE

    Do not use:

    • on wounds or damaged skin
    • with a heading pad

  • ASK DOCTOR

    Ask a doctor before use if you are:

    • prone to allergic reactions to salicylates, including aspirin
    • using a product on a child under 12 years of age

  • WHEN USING

    When using this product:

    • avoid contact with eyes and mucous membranes
    • use only as directed
    • do not bandage tightly

  • STOP USE

    Stop use and ask a doctor if:

    • Condition worsens
    • If symptoms persist for more than 7 days or clear up and occur within a few days
    • Excessive skin irritation occurs

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast feeding, ask a health professional before use.


  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed get medical help or contact a poison control center right away.


  • DOSAGE & ADMINISTRATION

    Directions:

    • Adults and children 12 years of age and older:  apply to affected area not more than 3 to 4 times daily
    • Children under 12 years of age: consult a physician
    • Apply generously and massage into affected area until completely absorbed
    • Apply before and after sports or exercise to help soothe aching muscles and muscle strain
    • Repeat as needed up to four times per day

  • STORAGE AND HANDLING

    Store at 20 to 25 degrees Celsius (68 to 77 degrees F)


  • INACTIVE INGREDIENT

    Aloe, Avocado Oil, Ceteareth-20, Cylcomethicone, Grape Seed Oil, MediFlex Relief Proprietary Herbal Extract Blend (juniper [berry], European Goldenrod [flower], Dandelion [leaf], Meadowsweet [herb], White Willow [bark], Methyl Glucose Sesquisterate, Natural Oil of Wintergreen, Phenoxyethanol Methylparaben, Shea Butter, Steareth-2, Stearath-10, Stearic Acid, Water


  • QUESTIONS

    Questions or comments?  1-877-309-8118 Monday through Friday, 9am-5pm. 


  • DESCRIPTION

    This product is manufactured exclusively for:  SAS Group, Inc., Tarrytown, NY 10591


  • PRINCIPAL DISPLAY PANEL

    Temporary Pain Relief

    Mediflex Relief Cream

    Temporary Relief of Minor Aches and Pains Associated with Arthritis, Simple Backache, Sprains, Bruises and Strains.

    • Soothing and medicated topical analgesic for aching joints and muscles
    • Effective for pre-exercise warm-up
    • Deep penetrating therapeutic pain relief
    • With skin moisturizing conditions aloe, shea butter, avocado, and grape seed oil
    • Contains MediFlex Relief's clinically tested herbal formula

    Mediflex Front

    Mediflex Back


  • INGREDIENTS AND APPEARANCE
    MEDIFLEX 
    menthol cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:67662-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5   in 85 g
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:67662-001-03 85 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 03/29/2010
    Labeler - SAS Group Inc. (948174057)
    Registrant - SAS Group Inc. (948174057)
    Establishment
    Name Address ID/FEI Business Operations
    SAS Group Inc. 948174057 relabel
    Establishment
    Name Address ID/FEI Business Operations
    Accupack Midwest Inc. 139637433 manufacture