FDA Label for Mencaine
View Indications, Usage & Precautions
Mencaine Product Label
The following document was submitted to the FDA by the labeler of this product Neptune Products. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredients (in each patch):
Lidocaine 4.5% Topical Anesthetic
Menthol 5% Topical Analgesic
Otc - Purpose
USES:
Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:
- Muscle soreness
- Strains
- Sprains
- Arthritis
- Simple backache
- Muscle stiffness
- Bruises
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
- 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
- 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
- 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
- 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
Do not use:
Ask a doctor before use if:
When using this product:
Stop use and consult your physician if:
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children, if put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches by folding sticky ends together.
Dosage & Administration
Adults, or children over the age of 12:
Apply patch to affected are 1 to 2 times daily or as directed
Children under 12 years of age:
Do not use
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
OTHER INFORMATION:
- Some individuals may not experience pain relief until several minutes or hours after applying the patch
- Store in a cool, dry place
- Protect product from excessive moisture or sunlight
- Store at 67-77o F (19-25o C)
Inactive Ingredient
INACTIVE INGREDIENTS:
Alcohol, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Glycerine, Kaolin, Partially Neutralized Polyacrylate, Phenoxyethanol, Polysorbate 80, Polyvinyl Pyrrolidone, Tartaric Acid, Tetrasodium EDTA, Water
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