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  5. Label Information: Ultra Lido Gel Patch

FDA Label for Ultra Lido Gel Patch

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT                                                          PURPOSES
    2. USES
    3. WARNINGS
    4. DIRECTIONS
    5. OTHER INFORMATION
    6. INACTIVE INGREDIENTS
    7. PRODUCT LABEL

Ultra Lido Gel Patch Product Label

The following document was submitted to the FDA by the labeler of this product Singular Dreamer, Ltd Dba True Marker. 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                                                          Purposes



Lidocaine 4.00% .....................................................Topical anesthetic


Uses



For temporary relief of pain.


Warnings



  • For External Use only

    • Do not use: ● More than 1 patch at a time ● On wounds or damaged skin ● With a heating pad ● If you are allergic to any ingredients of this product

      • When using this product:

      • Use only as directed ● Avoid contact with eyes, mucous membranes or rashes ● Do not bandage tightly

        • Stop use and ask a doctor if:

        • Localized skin reaction occur, such as rash, itching, redness, irritation, pain, swelling and blistering ● Condition worsens
          ● Symptoms persist for more than 7 days ● Symptoms clear up and occur again within a few days
          • If pregnant or breast-feeding, ask a health professional before use.
            • Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions



Adult and children 12 years of age and over:

  • Clean and dry affected area
  • Remove film from patch and apply to the skin
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Remove patch from the skin after at most 8-hour application

    • Children under 12 years of age: Consult a doctor.


Other Information



● Store at controlled room temperature 20° - 25°C (68° - 77°F)
● Avoid storing product in direct sunlight
● Protect product from excessive moisture


Inactive Ingredients



Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water),Carbomer, Cetearyl Alcohol, Ethylhexylglycerin, Glycol Stearate,
Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil,Phenoxyethanol,Polysorbate-60, Simmondsia Chinensis (Jojoba) Oil, Stearic Acid,
Triethanolamine.


Product Label



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