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
- 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 August 3, 2023
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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 not final part348 11/08/2022 Labeler - Neptune Products (081502369)