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
Drug Label Information
Updated November 3, 2023
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- Drug Facts
- Active Ingredients
- Purpose
- Uses
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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
- When Using This Product
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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
- Keep Out of Reach of Children
- Flammable
- Directions
- Other Information
- Inactive Ingredients
- Questions or Comments?
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INGREDIENTS AND APPEARANCE
NUVIRA
capsaicin 0.025%, menthol 10%, methyl nicotinate 0.25%, methyl salicylate 10% patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83295-3313 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYL NICOTINATE (UNII: 7B1AVU9DJN) (NIACIN - UNII:2679MF687A) METHYL NICOTINATE 0.0025 g in 1 g METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 0.1 g in 1 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.00025 g in 1 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 0.1 g in 1 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:83295-3313-5 5 in 1 POUCH 06/29/2023 1 8.5 g in 1 PATCH; Type 0: Not a Combination Product 2 NDC:83295-3313-1 6 in 1 BOX 06/29/2023 2 5 in 1 POUCH 2 8.5 g 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 Drug M017 06/29/2023 Labeler - Strand Health Group (118929144)