FDA Label for Theraworx Pain Relief Roll- On- Lidocaine

View Indications, Usage & Precautions

Theraworx Pain Relief Roll- On- Lidocaine Product Label

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

Drug Facts




Active Ingredient



Lidocaine Hydrochloride 4.00%


Purpose



Topical analgesic


Uses



For temporary relief of pain


Warnings



For external use only.


Do Not Use



in large quantities, particularly over raw surfaces or blistered areas


When Using This Product



avoid contact with the eyes


Stop Use And Ask A Doctor If



condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days


Keep Out Of 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:
  • shake bottle well
  • roll a thin layer to each affected area and allow to air dry
  • repeat
  • Wash hands after applying product
  • do not use more than 3 to 4 times daily
  • children under 2 years of age do not use: consult a doctor

Other Information



Store between 32°F and 120°F


Inactive Ingredients (Alphabetical)



Allantoin, Aloe barbadensis Leaf Extract, Aqua (Water), Benzyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Decyl Glucoside, Dimethyl Sulfoxide, Ethylhexylglycerin, Glycerin, Potassium Sorbate, Sanguinaria canadensis Root Extract, Silver Hydrosol, Sodium Benzoate, Tetrasodium EDTA, Xanthan Gum, Yeast Extract, Zingiber (Ginger) Root Extract


Package Labeling:




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