Label: NUVIRA- capsaicin 0.025%, menthol 10%, methyl nicotinate 0.25%, methyl salicylate 10% patch

  • NDC Code(s): 83295-3313-1, 83295-3313-5
  • Packager: Strand Health Group
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 3, 2023

If you are a consumer or patient please visit this version.

  • Drug Facts

  • 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

    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.

  • 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.

  • Questions or Comments?

    cs@strandhealthgroup.com

  • Principal Display Panel

    Nuvira Pouch

    Nuvira Box

  • INGREDIENTS AND APPEARANCE
    NUVIRA 
    capsaicin 0.025%, menthol 10%, methyl nicotinate 0.25%, methyl salicylate 10% patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83295-3313
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL NICOTINATE (UNII: 7B1AVU9DJN) (NIACIN - UNII:2679MF687A) METHYL NICOTINATE0.0025 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.1 g  in 1 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.00025 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    LEMON OIL, DISTILLED (UNII: ET5GD00TRP)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83295-3313-55 in 1 POUCH06/29/2023
    18.5 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:83295-3313-16 in 1 BOX06/29/2023
    25 in 1 POUCH
    28.5 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/29/2023
    Labeler - Strand Health Group (118929144)