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  5. Label Information: Theraworx Pm Nighttime Maximum Strength Pain Relief

FDA Label for Theraworx Pm Nighttime Maximum Strength Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREASTFEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS (ALPHABETICAL)
    14. THIS PACKAGE IS CHILD -RESISTANT. REPLACE CAP TIGHTLY
    15. PACKAGE LABELING:

Theraworx Pm Nighttime Maximum Strength Pain Relief 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 bilstered 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.


If Pregnant Or Breastfeeding,



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.


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, Parfum (Fragrance), Potassium Sorbate, Sanguinaria canadensis Root Extract, Silver Hydrosol, Sodium Benzoate, Tetrasodium EDTA, Xanthan Gum, Yeast Extract, Zingiber (Ginger) Root Extract


This Package Is Child -Resistant. Replace Cap Tightly




Package Labeling:



Label0 - Label0

Label0 - Label0


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