Label: LIDOPRO PATCH- lidocaine, menthol, and methyl salicylate patch
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Contains inactivated NDC Code(s)
NDC Code(s): 68788-9975-1 - Packager: Preferred Pharmaceuticals Inc.
- This is a repackaged label.
- Source NDC Code(s): 53225-1023
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated January 10, 2017
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- 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
• if allergic to any NSAIDS
• right before or after heart surgery
• any patch from a pouch that has been opened for 7 or more days
Ask a doctor before use if
• you are allergic to topical products
• the stomach bleeding warning applies to you
• you are taking a diuretic
• you have high blood pressure, heart disease, or kidney disease
• you are pregnant
When using this product
• wash hands after applying or removing patch
• 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 your physician if
• stomach pain or upset gets worse or lasts
• rash, irritation, or itching develops
• you feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding)
• condition worsens
- Directions
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Instructions for Use
• clean and dry affected area
• open pouch and remove one patch containing medical adhesive backing
• remove protective film from both patch and medical adhesive
• 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
• do not use more than 2 patches per day
• wash hands with soap and water after applying or removing patch
• reseal pouch containing unused patches after each use
Children under 18 years of age: Do not use
- Other information
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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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:68788-9975(NDC:53225-1023) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS .04 MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM .05 METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE .04 Inactive Ingredients Ingredient Name Strength ACRYLIC ACID (UNII: J94PBK7X8S) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) 2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYL ACRYLATE (UNII: WC487PR91H) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) NONOXYNOL-30 (UNII: JJX07DG188) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68788-9975-1 3 in 1 BOX 05/07/2015 1 5 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 05/07/2015 Labeler - Preferred Pharmaceuticals Inc. (791119022) Registrant - Preferred Pharmaceuticals Inc (791119022) Establishment Name Address ID/FEI Business Operations Preferred Pharmaceuticals Inc 791119022 RELABEL(68788-9975)