Label: LIDOPRO PATCH- lidocaine, menthol, and methyl salicylate patch
- NDC Code(s): 80425-0374-1
- Packager: Advanced Rx Pharmacy of Tennessee, LLC
- This is a repackaged label.
- Source NDC Code(s): 83881-401
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated February 29, 2024
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- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
• more than one patch on your bidy at a time or on cuts, irritated, or swollen skin
• on puncture wounds
• for more than one week without consulting a doctor.
When using this product
- Use only as directed. Read and follow directions and warning on this packaging.
- Do not apply to wounds or damaged, broken, or irritated skin
- Avoid contact with the eyes or mucous membranes
- Do not bandage tightly or apply local heat (such as heating pads) to area of use
- Do not use at the same time as other topical analgesics
- Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
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DIRECTIONS
adults and children over 12 years:
- clean and dry the affected area
- remove patch from plastic liner and place on the affected area
- use 1 patch for up to 12 hours
- place used patch on the liner when not in use
- re-use the patch up to 2 times.
children 12 years or younger: ask a doctor
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INGREDIENTS AND APPEARANCE
LIDOPRO PATCH
lidocaine, menthol, and methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80425-0374(NDC:83881-401) 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 0.5 mg in 100 mg METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.1 mg in 100 mg Inactive Ingredients Ingredient Name Strength POLYSORBATE 80 (UNII: 6OZP39ZG8H) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80425-0374-1 15 in 1 BOX 02/29/2024 1 2 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 02/29/2024 Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142) Establishment Name Address ID/FEI Business Operations Advanced Rx Pharmacy of Tennessee, LLC 117023142 repack(80425-0374)