Nuvira Patch

Nuvira Patch
SPL v3
SPL
SPL Set ID ff448183-03cf-df2d-e053-6394a90a77f0
Route
CUTANEOUS
Published
Effective Date 2024-08-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Niacin (0.0025 g) Salicylic Acid (0.1 g) Capsaicin (0.00025 g) Menthol
Inactive Ingredients
Sodium Polyacrylate (2500000 Mw) Water Sorbitol Dimethyl Sulfone Methylparaben Eucalyptus Oil Glycerin Arnica Montana Flower Polyacrylic Acid (250000 Mw) Ascorbic Acid Alpha-tocopherol Dihydroxyaluminum Aminoacetate Aloe Vera Leaf Frankincense Lemon Oil, Distilled Almond Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-29

Description

Capsaicin 0.025% Menthol 10% Methyl Nicotinate 0.25% Methyl Salicylate 10% (NSAID)

Purpose

Counterirritant Counterirritant Counterirritant Counterirritant


Medication Information

Purpose

Counterirritant

Counterirritant

Counterirritant

Counterirritant

Description

Capsaicin 0.025% Menthol 10% Methyl Nicotinate 0.25% Methyl Salicylate 10% (NSAID)

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

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:

  • 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

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.

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
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
Other Information
  • Store in a cool, dry place with lid tightly closed.
  • If the tamper-evident foil seal is not intact, do not use
Active Ingredients

Capsaicin 0.025%

Menthol 10%

Methyl Nicotinate 0.25%

Methyl Salicylate 10% (NSAID)

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.

Questions Or Comments?
Principal Display Panel

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


Structured Label Content

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.

Purpose

Counterirritant

Counterirritant

Counterirritant

Counterirritant

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

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:

  • 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

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.

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
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
Other Information
  • Store in a cool, dry place with lid tightly closed.
  • If the tamper-evident foil seal is not intact, do not use
Active Ingredients

Capsaicin 0.025%

Menthol 10%

Methyl Nicotinate 0.25%

Methyl Salicylate 10% (NSAID)

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.

Questions Or Comments? (Questions or Comments?)
Principal Display Panel

When Using This Product

Avoid contact with the eyes and mucous membranes

Stop Use and Ask A Doctor If (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 (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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)