Label: LIDOREAL PATCH- lidocaine and menthol patch
- NDC Code(s): 81877-725-15
- Packager: FORREAL PHARMACEUTICALS LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 17, 2024
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- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
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Warnings
For external use only
Do not use
- on the face or rashes, on wounds or damaged skin
- in the eyes, mouth, or other mucous membranes
- on genitals
- with a heating pad
- right before or after heart surgery
- any patch from a pouch that has been opened for 7 or more days
- in large quantities, particularly over raw surfaces or blistered areas
- if tamper-evident seal is torn, broken, or missing
- more than 2 patches per day unless directed by a doctor
- children under 18 years of age
Ask a doctor before use if you have
- allergies to topical products
- high blood pressure, heart disease, or kidney disease.
When using this product
- avoid contact with eyes. If eye contact occurs, rinse thoroughly with water
- the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.
Stop use and consult a doctor if
condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
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Directions
Adults 18 years and older:
- clean and dry affected area
- open pouch and remove one patch
- remove protective film from patch
- apply one patch to the affected area of pain and leave in place for 8 to 12 hours
- if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours
- only use one patch at a time
- wash hands with soap and water after applying or removing patch
- reseal pouch containing unused patches after each use
- Other information
- Inactive Ingredients
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INGREDIENTS AND APPEARANCE
LIDOREAL PATCH
lidocaine and menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:81877-725 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 mg Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) EDETATE DISODIUM (UNII: 7FLD91C86K) GLYCERIN (UNII: PDC6A3C0OX) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) KAOLIN (UNII: 24H4NWX5CO) MINERAL OIL (UNII: T5L8T28FGP) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POVIDONE K90 (UNII: RDH86HJV5Z) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:81877-725-15 15 in 1 BOX; Type 0: Not a Combination Product 05/15/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 05/15/2024 Labeler - FORREAL PHARMACEUTICALS LLC (118029197)