Active Ingredient
Lidocaine
Signature Care Medicated Pain Relief Patch
FDA Label NDC 21130-988
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safeway, Inc. for the product Signature Care Medicated Pain Relief Patch (NDC 21130-988). 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, purpose, use, warning, do not use, when using this product, stop use and consult a doctor if, if pregnant or breastfeeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical anesthetic
Use
For temporary relief of pain
Warning
For external use
Do Not Use
■ More than one patch on your body at a time ■On cut, irritated or swollen skin ■On puncture wounds ■Over raw surfaces or blistered areas ■ For more than one week without consulting a doctor ■ If you are allergic to any active or inactive ingredients■ If pouch is damaged or opened.
When Using This Product
■Use only as directed■Read and follow all directions and warnings on this carton ■Do not allow contact with the eyes ■Do not use at the same time as other topical analgesics ■Do not bandage tightly or apply local heat (such as heating pads) to the area of use ■ Do not microwave ■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 Consult A Doctor If
■ Condition worsens ■ 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 Breastfeeding
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 (1-800-222-1222) right away.
Directions
■Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use ■Children under 12 years of age: consult a physician.
Other Information
Other information
Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.
Inactive Ingredients
aluminum glycinate, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, pov done, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol
* Please review the disclaimer below.
