Label: MEDIFLEX- menthol cream

  • 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 April 7, 2010

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  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:67662-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5   in 85 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67662-001-0385 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/29/2010
    Labeler - SAS Group Inc. (948174057)
    Registrant - SAS Group Inc. (948174057)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAS Group Inc.948174057relabel
    Establishment
    NameAddressID/FEIBusiness Operations
    Accupack Midwest Inc.139637433manufacture
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