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  5. Label Information: Avalin External Analgesic Patch

FDA Label for Avalin External Analgesic Patch

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRODUCT LABEL

Avalin External Analgesic Patch Product Label

The following document was submitted to the FDA by the labeler of this product Rxchange Co.. 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 Ingredients



Lidocaine 4%

Menthol 1%


Purpose



External Analgesic


Uses



For the temporary relief pain associated with • minor cuts  • scrapes  • minor skin imitations


Warnings



For external use only


Do Not Use



• in large quantities, particularly over raw surfaces or blistered areas

• other than directed by a doctor  • on open wounds or damaged skin

• with a bandage to cover the surface  • for longer than 5 consecutive days


Ask A Doctor Before Use



if used for children under 12.


When Using This Product



avoid contact with the eyes.


Stop Use And Ask A Doctor



• 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 Reach Of Children.



If swallowed, get a medical help or contact Poison Control Center right away.


Directions



  • Adults and children 2 years of age and older: Apply to the affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: Consult a doctor.
  • Clean and dry affected area.
  • Remove patch from backing and apply to affected area.
  • Use one patch at a time.
  • Leave patch on affected area for up to 8-hours at a time

Other Information



Store in dry area between 59-79 F(15-26 C)


Inactive Ingredients



acrylic acid, aluminum hydroxide, carmellose sodium, 2-ethylhexyl acrylate, glycerin, isopropyl myristate, methyl acrylate, nonoxynol-30, polyacrylate, polyacrylic acid, polysorbate 80, sorbitan sesquioleate, starch, talc, tartaric acid, titanium dioxide, water


Questions Or Comments?



Please call (818) 545-1177


Product Label



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