Active Ingredient
Lidocaine 4%
Dr. Scholls Blister Pain Relief Complete Kit
FDA Label NDC 73469-0485
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Scholl's Wellness Company Llc for the product Dr. Scholls Blister Pain Relief Complete Kit (NDC 73469-0485). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purposes, uses, warnings, do not use:, when using this product:, stop use and ask a doctor if:, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purposes
External Analgesic
Uses
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
■ 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
■ Avoid contact with eyes and mucous membranes.
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 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
Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, Polyvinylpyrrolidone (PVP), Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water/Aqua/Eau
Questions Or Comments
1-866-360-3226
Package Label. Principal Display Panel
Patch (Patch)
73469-0485 (73469 0485)
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