NDC | 69833-011-15 |
Set ID | 3272a371-9617-4b82-8930-803430612675 |
Category | HUMAN OTC DRUG LABEL |
Packager | Spring Hill Therapeutics LLC |
Generic Name | |
Product Class | Amide Local Anesthetic, Antiarrhythmic |
Product Number | |
Application Number | PART348 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Uses
- Warnings
- Directions
- Other Ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - 15 Patch Carton
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INGREDIENTS AND APPEARANCE
SOLMARA
menthol, unspecified form and lidocaine patchProduct 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)