SOLMARA- menthol, unspecified form and lidocaine patch

Solmara by

Drug Labeling and Warnings

Solmara by is a Otc medication manufactured, distributed, or labeled by Spring Hill Therapeutics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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.

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.

QUESTIONS

FOR QUESTIONS CALL 813-388-8735

PRINCIPAL DISPLAY PANEL - 15 Patch Carton

NDC: 69833-011-15

Solmara
Lidocaine 4%,Menthol 5%

15
Patches

INGREDIENTS AND APPEARANCE

SOLMARA 
menthol, unspecified form and lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69833-011
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A)	Menthol, Unspecified Form	5 g
Lidocaine (UNII: 98PI200987) (Lidocaine - UNII:98PI200987)	Lidocaine	4 g

Inactive Ingredients
Ingredient Name	Strength
2-Ethylhexyl Acrylate (UNII: HR49R9S6XG)
Methacrylic Acid (UNII: 1CS02G8656)
Bentonite (UNII: A3N5ZCN45C)
Sodium Stearate (UNII: QU7E2XA9TG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69833-011-15	5 in 1 CARTON
1		3 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	07/20/2015

Labeler - Spring Hill Therapeutics LLC (079813250)