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  5. Label Information: Dr. Scholls Blister Pain Relief Complete

FDA Label for Dr. Scholls Blister Pain Relief Complete

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USE
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. QUESTIONS?
    15. PACKAGE LABELING:

Dr. Scholls Blister Pain Relief Complete Product Label

The following document was submitted to the FDA by the labeler of this product Scholl's Wellness Company 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.

Drug Facts




Active Ingredient



Lidocaine 4%


Purpose



External Analgesic


Use



Temporarily relieves pain


Warnings



For external use only

  • Avoid contact with eyes
  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor.

Do Not Use



  • More than one patch on your body at a time
  • If you have had an allergic reaction to lidocaine or other local anesthetics
  • Do not use in large quantities, particularly over raw surfaces or blistered areas
  • 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

Stop Use And Ask A Doctor If



  • condition worsens
  • severe burning sensation, redness, rash or 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 care 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 over 12 years:

Step 1 (Lidocaine patch application) • apply to the affected area not more than 3-4 times daily

  • clean and dry affected area
  • remove backing from lidocaine patch by firmly grasping both ends and gently pulling away backing
  • once exposed portion of patch is positioned, carefully remove remaining backing completely to apply patch to affected area
  • once applied, press firmly on patch to help adhesive adhere to blister
  • do not remove patch and reapply
  • once patch is applied, move to Step 2.

    • Step 2 (Bandage application) •remove backing film from hydrogel bandage marked "Step 1" and place center (adhesive side down) over skin to seal lidocaine patch and blister.

    • remove backing film marked "Step 2" and firmly smooth down adhesive edge to skin to seal lidocaine patch and blister. Replace when bandage begins to loosen

      • children 12 years or younger: ask a doctor


Other Information



Store between 20-25°C (68-77°F)


Inactive Ingredients



Cellulose Gum, Dihydroxyaluminum Aminoacetate, Ethylhexylglycerin, Glycerol, Laurocapram, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Polyacrylic Acid, Propylene Glycol, Silica Silylate, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Tocopherol Acetate, Vanillyl Butyl Ether, Urea, Water (Aqua)


Questions?



1-866-360-3226


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