SOLMARA- menthol, unspecified form and lidocaine patch 
Spring Hill Therapeutics LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Solmara

Drug Facts

Active IngredientsPurpose
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.

Warnings

Only for external use. Use only as directed or by a health professional.

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.

Keep out of the reach of children. Consult physician for children under 12.

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.

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
SOLMARA 
menthol, unspecified form and lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69833-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form5 g
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987) Lidocaine4 g
Inactive Ingredients
Ingredient NameStrength
2-Ethylhexyl Acrylate (UNII: HR49R9S6XG)  
Methacrylic Acid (UNII: 1CS02G8656)  
Bentonite (UNII: A3N5ZCN45C)  
Sodium Stearate (UNII: QU7E2XA9TG)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69833-011-155 in 1 CARTON
13 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34807/20/2015
Labeler - Spring Hill Therapeutics LLC (079813250)

Revised: 7/2015
Document Id: 41a21ee8-6884-447d-893d-1c44f4aaba33
Set id: 3272a371-9617-4b82-8930-803430612675
Version: 1
Effective Time: 20150721
 
Spring Hill Therapeutics LLC