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  5. Label Information: Mediflex

FDA Label for Mediflex

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK DOCTOR
    7. OTC - WHEN USING
    8. OTC - STOP USE
    9. OTC - PREGNANCY OR BREAST FEEDING
    10. OTC - KEEP OUT OF REACH OF CHILDREN
    11. DOSAGE & ADMINISTRATION
    12. STORAGE AND HANDLING
    13. INACTIVE INGREDIENT
    14. OTC - QUESTIONS
    15. DESCRIPTION
    16. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mediflex Product Label

The following document was submitted to the FDA by the labeler of this product Sas Group Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Menthol 5%


Otc - 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.


Otc - Do Not Use



Do not use:

  • on wounds or damaged skin
  • with a heading pad

Otc - 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

Otc - When Using



When using this product:

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

Otc - 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

Otc - Pregnancy Or Breast Feeding



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


Otc - 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


Otc - 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


Package Label.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 - MediflexFront

    Mediflex Front - MediflexFront




* Please review the disclaimer below.