FDA Label for Nuvira
View Indications, Usage & Precautions
Nuvira Product Label
The following document was submitted to the FDA by the labeler of this product Strand Health Group. 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.
Active Ingredients
Capsaicin 0.025%
Menthol 10%
Methyl Nicotinate 0.25%
Methyl Salicylate 10% (NSAID)
Purpose
Counterirritant
Counterirritant
Counterirritant
Counterirritant
Uses
For the temporary relief of joint pain, muscle pain, and inflammation associated with:
- Arthritis
- Backache
- Discomfort
- Cramps
- Neckache
- Soreness
- Sprains
- Strains
This product may take up to 7 days to work for arthritis pain.
Warnings
For External Use Only Topical use only
Allergy Alert: NSAIDs may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include:
- Hives
- Asthma (wheezing)
- Skin Reddening
- Blisters
- Facial Swelling
- Shock
- Rash
- Are age 60 or older
- Have had stomach ulcers or bleeding problems
- Take a blood thinning (anticoagulant) or steroid drug
- Take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen or others)
- Have 3 or more alcoholic drinks every day while using this product
- Apply more or for longer than directed
If an allergic reaction occurs, stop use and seek medical attention immediately.
Liver Warning: This product contains an NSAID. Liver damage may occur if you apply (1) more or for a longer time than directed or (2) when using other drugs containing an NSAID.
Stomach Bleeding Warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is small, but higher if you:
Heart Attack and Stroke Warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.
Do Not Use
- On damaged, irritated, or infected skin
- With a bandage or heating pad
- If you are allergic to any ingredients in this product
- Right before or after heart surgery
- In the eyes, nose, or mouth
- Otherwise as directed
When Using This Product
Avoid contact with the eyes and mucous membranes
Stop Use And Ask A Doctor If
- Any of the Warnings apply to you
- You are taking a diuretic
- You are taking any other drugs
- You have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
- Excessive skin irritation develops
- Condition worsens
- Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days
If Pregnant Or Breast-Feeding
Ask a health professional before use. It is especially important not to use NSAIDs at 20 weeks or later in pregnancy, unless directed by a doctor to do so.
Keep Out Of Reach Of Children
If ingested seek medical help or contact a Poison Control Center immediately
Flammable
Keep away from excessive heat or open flame
Directions
Adults and Children 12 Years of Age and Older:
- Clean and dry the affected area
- Apply gel pad directly to your skin for up to 12 hours
- Gel pad can be cut into pieces and used on up to 2 body parts at a time
- One application per day is recommended
- Wash hands immediately after use
Other Information
- Store in a cool, dry place with lid tightly closed.
- If the tamper-evident foil seal is not intact, do not use
Inactive Ingredients
Aloe Vera Gel, Arnica, Boswellia, Citris Limon (Lemon Oil), Dihydroxyaluminum Aminoacetate, Dimethyl Sulfone (DMSO2), Eucalyptus Oil, Glycerol, Methylparaben, Polyacrylic Acid, Prunis Amygdalus Dulcis (Almond Oil), Pure Water, Sodium Polyacrylate, Sorbitol, Vitamin C, Vitamin E.
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