Label: LIDOPRO PATCH- lidocaine and menthol patch
- NDC Code(s): 80425-0380-1
- Packager: Advanced Rx Pharmacy of Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 53225-1123
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 2, 2024
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Uses
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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
LIDOPRO PATCH
lidocaine and menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80425-0380(NDC:53225-1123) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 mg in 100 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1 mg in 100 mg Inactive Ingredients Ingredient Name Strength METHYLPARABEN (UNII: A2I8C7HI9T) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) GLYCERIN (UNII: PDC6A3C0OX) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) TARTARIC ACID (UNII: W4888I119H) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80425-0380-1 3 in 1 BOX 04/02/2024 1 5 in 1 POUCH 1 8500 mg in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 04/02/2024 Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142) Establishment Name Address ID/FEI Business Operations Advanced Rx Pharmacy of Tennessee, LLC 117023142 repack(80425-0380)
