Nuvira Patch

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-03-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:08:46

Label at a glance#

ProductNuvira
Active ingredientMETHYL NICOTINATE, METHYL SALICYLATE, CAPSAICIN, MENTHOL
Label structure15 sections

Indications and 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.

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Capsaicin 0.025%

Menthol 10%

Methyl Nicotinate 0.25%

Methyl Salicylate 10% (NSAID)

Purpose

OTC - PURPOSE SECTION

Counterirritant

Counterirritant

Counterirritant

Counterirritant

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

For External Use OnlyTopical 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

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

Avoid contact with the eyes and mucous membranes

Stop Use and Ask a Doctor If

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested seek medical help or contact a Poison Control Center immediately

Flammable

SPL UNCLASSIFIED SECTION

Keep away from excessive heat or open flame

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

cs@strandhealthgroup.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83295-3313-1EA - Each83295-3313b6c7ce3b-5cee-4800-9f41-cad90ab6638d12023-09-05
83295-3313-5EA - Each83295-3313b40f4116-fdeb-44b9-ba62-b319e642fa2b12023-09-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80425-035680425-0356-1
83295-3313

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NuviraCAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10%Strand Health Groupff448183-03cf-df2d-e053-6394a90a77f02024-08-16WarningsExact identifier
ndc (product): 83295-3313
137b7024-b667-9287-e063-6394a90aa6fe087c4fcd-2e74-1b31-e063-6394a90a1ef62024-03-12WarningsExact identifier
spl id: 137b7024-b667-9287-e063-6394a90aa6fe
spl set id: 087c4fcd-2e74-1b31-e063-6394a90a1ef6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.