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  5. Label Information: Firstcare Pain Relief Gel Patch

FDA Label for Firstcare Pain Relief Gel Patch

View Indications, Usage & Precautions

Table of Contents

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

Firstcare Pain Relief Gel Patch Product Label

The following document was submitted to the FDA by the labeler of this product Uspharma Ltd. 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



Lidocaine 4%


Purpose



Topical Anesthetic


Uses



Temporarily relieves minor pain


Warnings



For external use only


Do Not Use



  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When Using This Product



  • use only as directed. Read and follow all directions and warnings on this carton.
  • do not allow contacts with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop Use And Ask A Doctor If



  • condition worsen
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • you experience signs of skin injury, such as pain , swelling, or blistering where the product was applied

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children And Pets.



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


Directions



adults and children over 12 years:

  • clean and dry affected area
  • remove film from patch
  • carefully apply patch to affected area
  • use 1 patch for up to 12 hours

    • children 12 years or younger: ask a doctor


Inactive Ingredients



polyvinyl alcohol, non-crystalizing sorbitol solution, polyacrylic acid, glycerin, carboxymethylcellulose sodium, colloidal silicon dioxide, titanium dioxide, propylene glycol, tartaric acid, magnesium hydroxide, sodium polyacrylate, purified water


Package/Label Principal Display Panel



FIRST CARE TM ​

***MADE IN USA***

LASTS UP TO 12 HOURS

MAXIMUM STRENGTH**

PAIN RELIEF GEL PATCH

FOR BACK, SHOULDER, NECK & JOINTS


Lidocaine 4%

Targets Muscle and Nerve Pain

Odor & Paraben Free


3-15/16” x 5-1/2” (10 cm x 14 cm)

NDC 71594-602-05

5 PATCHES

Individually sealed in child resistant packages

Carton Image - lidocaine patch 01

Carton Image - lidocaine patch 01


* Please review the disclaimer below.