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  5. Label Information: Flex24 Pain

FDA Label for Flex24 Pain

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT
    6. STOP USE AND ASK A DOCTOR IF
    7. CAUTION
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Flex24 Pain Product Label

The following document was submitted to the FDA by the labeler of this product Flex24, 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.

Active Ingredients



Menthol, 10%

Camphor, 3%


Purpose



Topical Analgesic


Uses



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


Warnings



For external use only


Do Not



Apply to open wounds, or damaged, broken, or irritated skin


Stop Use And Ask A Doctor If



conditions worsens or if symptoms persist for more than 7 days


Caution



  • Discontinue use if there is redness or excessive irritation on skin
  • Avoid contact with eyes
  • Arthritis: If pain persists more than 10 days or redness is present, or in conditions affecting children under 12 years of age, consult a physician immediately

Otc - Keep Out Of Reach Of Children



Keep out of the reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • Adults and children 2 years of age and older: Apply to the affected area not more than 3 times daily
  • Children under 2 years old: consult a doctor
  • Tear and apply in a circle of 25 mm diameter to affected area and spread smoothly over the skin with fingers
  • Wash fingers that applied cream with water.  Do not rub eyes with fingers until washed with water

Inactive Ingredients



Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aqua (Deionized water), Arnica Montana flower extract, Ascorbic Acid (Vitamin C), Beta Glucan, Boswellia Extract, Ceramide NG, Cetearyl Olivate, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Distearyldimonium Chloride, Gluconolactone, Glyceryl Stearate, Glycerin, Helianthus Annuus (sunflower) oil, Lactic acid, Magnesium Sulfate, Melaleuca Alternifolia (Tea tree) oil, Xanathan Gum, Methylsulfonylmethane (MSM), PPG 12/SMD1 copolymer, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, SD-Alcohol 40B, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol


Package Label.Principal Display Panel



FLEX24

RECOVER NATURALLY

PAIN CREAM

SAMPLE PACK

NET wt. 0.14 oz (3.8g)

Dist: FLEX24, INC.

4020 GALT OCEAN DRIVE, STE. 1607

FORT LAUDERDALE, FL 33308

CALL TOLL FREE 844.4.FLEX24

NDC 73218-001-01


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