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  5. Label Information: Hot And Cold Lidocaine With Menthol Patch Pain Relief

FDA Label for Hot And Cold Lidocaine With Menthol Patch Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. OTC - PREGNANCY OR BREAST FEEDING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hot And Cold Lidocaine With Menthol Patch Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Velocity Pharma Llc. 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.

Other



Drug Facts


Otc - Purpose



Active IngredientsPurpose
Lidocaine 4 % (240 mg)Topical analgesic
Menthol 1%     (60 mg)Topical analgesic


Uses



Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.


Warnings



For external use only.


Otc - Do Not Use



Do not use if you are allergic or sensitive to lidocaine or menthol. Do not use if pouch is damaged or opened.


When Using This Product



  • use only as directed
  • avoid contact with eyes or mucous membranes
  • do not apply to open wounds or sensitive skin
  • do not bandage tightly or use a heating pad

Stop Use And Ask A Doctor If



  • excessive redness or irritation is present
  • condition worsens
  • pain persists for more than 7 days
  • symptoms clear up and occur again within a few days

Otc - Pregnancy Or Breast Feeding



If pregnant or breast-feeding, ask a health professional before use.


Otc - Keep Out Of Reach Of Children



Keep out of Reach of children. If swallowed, get medical help or contact a Poison control Center right away.


Directions



  • adults: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.
  • children: consult your physician
  • remove protective film, gently apply to affected area.

Inactive Ingredients



Dihydroxyaluminium aminoacetate, disodium EDTA, glycerin, methylparaben, polyvinyl alcohol, propyl
paraben, propylene glycol, purified water, sodium carboxymethyl cellulose, sodium polyacrylate, tartaric
acid, titanium dioxide


Package Label.Principal Display Panel



Final - Final

Final - Final


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