Other
Drug Facts
Solmara
FDA Label NDC 69833-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Spring Hill Therapeutics Llc for the product Solmara (NDC 69833-011). 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, otc - when using, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, directions, 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 | |
|---|---|---|
| Menthol | 5.00% | Topical Analgesic |
| Lidocaine | 4.00% | Topical Anesthetic |
Uses
For the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.
Otc - When Using
Only for external use. Use only as directed or by a health professional.
Otc - Do Not Use
Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.
Do not cover with bandage.
Otc - Keep Out Of Reach Of Children
Keep out of the reach of children. Consult physician for children under 12.
Otc - Pregnancy Or Breast Feeding
Consult your physician: if pregnant or pain persists or worsens.
Directions
Adults and children 12 years and over. Apply patch to affected area 1 to 2 times daily or as directed.
Instruction For Use
Clean and dry the affected area
Open pouch and remove one patch
Remove any protective film and apply directly to affected area of pain
Wash hands with soap and water after applying patch
Reseal pouch containing unused patches after each use
Other Ingredients
Methacrylic acid, ethylhexylacrylate, bentonite, sodium stearate.
Otc - Questions
FOR QUESTIONS CALL 813-388-8735
Principal Display Panel - 15 Patch Carton
NDC 69833-011-15
Solmara
Lidocaine 4%,Menthol 5%
15
Patches
Principal Display Panel (15 Patch Carton)
* Please review the disclaimer below.
