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Drug Facts
MFG by JAR Laboratories, Elmhurst, IL 60126
Lidopatch
FDA Label NDC 50682-527
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by 3t Federal Solutions Llc for the product Lidopatch (NDC 50682-527). 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 other, otc - purpose, uses, warnings, otc - do not use, when using this product, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
| Active Ingredients | Purpose |
|---|---|
| Lidocaine 3.99% | Topical analgesic |
| Menthol 1% | Topical analgesic |
Uses
Temporarily relieves minor pain associated with: arthritis, simple backache, bursitis, tendonitis, muscle strains, sprains & bruises.
Warnings
For external use only.
Otc - Do Not Use
Do not use if you are allergic or sensitive to lidocaine or menthol. Do not use if pouch is damaged or opened.
When Using This Product
❏ use only as directed❏ avoid contact with eyes or mucous membranes❏ do not apply to open wounds or sensitive skin❏ do not bandage tightly or use a heating pad
Stop Use And Ask A Doctor If
❏ excessive redness or irritation is present❏ condition worsens❏ pain persists for more than 7 days❏ symptoms clear up and occur again within a few days
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of Reach of children. If swallowed, get medical help or contact a Poison control Center right away.
Directions
❏ adults: apply patch to affected area for a maximum of 12 hours. Do not use more than 1 patch every 24 hours.❏ children: consult your physician❏ remove protective film, gently apply to affected area.
Inactive Ingredients
Glycerol, Water, Acrylamide/acrylate co-polymer, (Poly) vinyl pyrrolidone, Germaben II
Questions?
Email [email protected]
Principal Display Panel - 3 Topical Patch Carton
NDC 50682 527 03
GET PAIN
RELIEF NOW!
LidoPatch®
CONTAINS LIDOCAINE
PAIN
RELIEF
PATCH
✔ SAME ACTIVE INGREDIENT AS
LEADING PRESCRIPTION PATCH✔ ONE PATCH FOR 24 HOUR PAIN RELIEF✔ FOR RELIEF OF LOCALIZED PAIN✔ FAST ACTING✔ ULTRA THIN, FLEXIBLE, TRIM TO FIT
3 TOPICAL PATCHES PER BOX
Principal Display Panel (3 Topical Patch Carton)
* Please review the disclaimer below.
