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  5. Label Information: Dorflex Icy Hot Flexible, Small

FDA Label for Dorflex Icy Hot Flexible, Small

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. PRECAUTIONS
    11. INACTIVE INGREDIENTS
    12. OTHER INFORMATION
    13. PRINCIPAL DISPLAY PANEL - SMALL
    14. PRINCIPAL DISPLAY PANEL - LARGE
    15. PRINCIPAL DISPLAY PANEL - EXTRA LARGE

Dorflex Icy Hot Flexible, Small Product Label

The following document was submitted to the FDA by the labeler of this product Lead Chemical Co., Ltd.. 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 Ingredient



Menthol 5%


Purpose



Topical analgesic


Uses



Dorflex Icy Hot is indicated for bruises, traumas, muscle pains, cramps, torticollis and painful and inflammatory processes at large.


Warnings



For external use only

For use in adults and children over 12 years.


When Using This Product



  • Use only as directed.
  • Do not use with a heating pad.
  • Avoid contact with eyes and mucous membranes.
  • Do not apply to wounds or damaged, broken or irritated skin.

Stop Use And Ask A Doctor If



  • Condition worsens.
  • Irritation or redness develops.
  • Symptoms persist for more than 7 days or clear up and occur again within a few days.

If Pregnant Or Breast-Feeding,



ask a doctor before use.


Keep Out Of Reach Of Children.



If swallowed by accident, get medical help.


Directions



  • Remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
  • Carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
  • Once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area

    • Children 12 years or younger, ask a doctor


Precautions



  • Do not wear the same patch for more than 8 hours.
  • Do not wear more than 3 patches daily.
  • Store in ambient temperature.
  • Use each patch only once.

Inactive Ingredients



acrylic acid, aluminum hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water


Other Information



Responsible pharmacist: Antonia A. Oliveira - CRF-SP 5.854. MS 8013490015

Manufactured by: Lead Chemical Company, Ltd., 77-3 Himata, Toyama City, 930-0912. Toyama, Japan. Packaged by: Chattem, Inc., 1715 West 38th Street, Chattanooga, Tennessee, 37409. United States. Imported by: Sanofi-Aventis Farmaceutica Ltda. Rua Conde domingos Papais, 413 - Suzano - SP - CEP 08613-010. CNPJ 02.685.377/0008-23.


Principal Display Panel - Small



Dorflex ICY HOT® Flexible Patch

Principal Display Panel - Large



Dorflex ICY HOT® Flexible Patch

  • Muscle pain
  • Bruises
  • Cramps
  • Torticollis
     

    • Lasts up to 8 hours

    Contains 5 Patches in 1 Resealable Pouch

    Cut open pouch and remove pad

    Reseal pouch after opening

    Pouch Label - Large

Principal Display Panel - Extra Large



Dorflex ICY HOT® Flexible Patch

  • Muscle pain
  • Bruises
  • Cramps
  • Torticollis
     

    • Lasts up to 8 hours

    Contains 3 Patches in 1 Resealable Pouch

    Cut open pouch and remove pad

    Reseal pouch after opening

    Pouch Label - Extra Large

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