Label: MENCAINE- lidocaine, menthol patch
- NDC Code(s): 72594-1090-1, 72594-1090-5
- Packager: Neptune Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 17, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
-
WARNINGS
WARNINGS:
For external use only
This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you:
- Are age 60 or older
- Have had stomach ulcers or bleeding problems
- Take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others)
- Take a blood thinning (anticoagulant) or steroidal drug
- Have three or more alcoholic drinks every day while using this product
- Take more or for a longer time than directed
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 NSAID’s
- 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 takin 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
If pregnant or breast feeding, ask a doctor before use while breast feeding and during the first 6 months of pregnancy. Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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INDICATIONS & USAGE
INSTRUCTIONS FOR USE:
- 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
- Do not use more than 2 patches per day
- Wash hands with soup and water after applying or removing patch
- Reseal pouch containing unused patches immediately after each use
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
MENCAINE
lidocaine, menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72594-1090 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4.5 mg in 100 mg MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 mg in 100 mg Inactive Ingredients Ingredient Name Strength VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9) TARTARIC ACID (UNII: W4888I119H) WATER (UNII: 059QF0KO0R) KAOLIN (UNII: 24H4NWX5CO) POLYSORBATE 80 (UNII: 6OZP39ZG8H) DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5) CARBOXYMETHYLCELLULOSE SODIUM (0.7 CARBOXYMETHYL SUBSTITUTION PER SACCHARIDE; 100-200 MPA.S AT 1%) (UNII: 99H65D77XY) .ALPHA.-ISOBUTYLPHENETHYL ALCOHOL (UNII: 2SBL0E1I0N) GLYCERIN (UNII: PDC6A3C0OX) PHENOXYETHANOL (UNII: HIE492ZZ3T) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72594-1090-1 1 mg in 1 POUCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug 11/08/2022 2 NDC:72594-1090-5 5 in 1 BOX 11/08/2022 2 3 in 1 POUCH 2 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 11/08/2022 Labeler - Neptune Products (081502369)