Active Ingredient
Lidocaine 4%
Care Science Patch
FDA Label NDC 51142-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Aso Llc for the product Care Science (NDC 51142-100). 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, 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
Purpose
Topical Analgesic
Uses
- For the temporary relief of pain
Warnings
For external use only
Do Not Use
- large quantities
- on raw surfaces, blistered areas, wounds or damaged skin
- if you are allergic to any ingredients of this product
When Using This Product
- do not use other topical products
- do not allow contact with eyes or mucous membranes
- apply only to clean, dry, and untreated skin
- use only as directed
Stop Use And Ask A Doctor If
- skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
- 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 care professional before use.
Keep Out Of Reach Of Children.
If put in mouth, get medical help or contact a Poison Control Center right away (1-800-222-1222).
Directions
- Adults and children 12 years and over: clean and dry affected area
- peel film from patch and plastic liner and apply to the skin
- apply 1 patch at a time to affected area, not more than 3 to 4 times daily
- wash hands after applying patch
- remove patch from the skin after at most 8 hours application
- Children under 12 years of age: do not use, consult a physician before use.
Other Information
- Store at room temperature
- keep away from excessive heat
- do not exceed 100 oF (38 oC)
Inactive Ingredients
acrylic adhesive, polyester fabric
Principal Display Panel
CARE SCIENCE
4% LIDOCAINE PAIN RELIEF
BLISTER DEFENSE PATCH
DESIGNED FOR TOES AND HEELS
LASTS UP TO 8 HOURS
Maximum OTC Strength
- For temporary relief of pain associated with pressure and friction
- Lidocaine in adhesive temporarily numbs pain
- Covers and Protects Skin
- Durable, Breathable
- Thin and Flexible Fabric Easily conforms to Skin
Flexible Fabric
Product Label (2000485 Csc Lidocaine)
* Please review the disclaimer below.
