FDA Label for Asperflex Original Maximum Strength

View Indications, Usage & Precautions

Asperflex Original Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Akron Pharma 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 Ingredient



Menthol 7.5%


Purpose



Topical analgesic


Uses



for the temporary relief of minor aches and pains of muscles and joints associated with:

■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises


Warnings



For external use only


Do Not Use



■ on wounds, damaged, broken or irritated skin

■ with a heating pad or apply local heat to the area of use


When Using This Product



  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contact with
  • the eyes and mucous membranes
  • rare cases of serious burns have been reported with products of this type
  • do not apply to wounds or damaged, broken or irritated skin
  • do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
  • do not use at the same time as other topical analgesics
  • a transient burning sensation may occur upon application but generally disappears in several days
  • avoid applying into skin folds <do not use more than 4 patches at a time

Stop Use And Ask A Doctor If



condition worsens or symptoms persist for more than 7 days

■ symptoms clear up and occur again within a few days

■ severe burning sensation, redness or irritation develop

■ you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied


If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).


Directions



adults and children 12 years of age and older:

■ gently fold the patch in half to remove center section of film backing. Apply the exposed adhesive portion to the site of pain.

■ remove remaining film backing from both sides and finish applying to skin

■ apply to affected area not more than 3 to 4 times daily

children under 12 years of age: consult a doctor


Other Information



store at room temperature 15°-30°C (59°-86°F).


Inactive Ingredients



aluminum glycinate, propylene glycol, sodium acrylate/sodium acryloyldimethyl taurate copolymer, tartaric acid, 2,4-Imidazolidinedione, disodium edta, water, glycerin


Questions Or Comments?



Call toll-free 1-877-255-6999.


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