Nuvira Patch by Strand Health Group Nuvira Patch

Nuvira Patch by

Drug Labeling and Warnings

Nuvira Patch by is a Otc medication manufactured, distributed, or labeled by Strand Health Group. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NUVIRA PATCH- diclofenac 1%, lidocaine 4%, menthol 5%, capsaicin 0.01%, methyl salicylate 8% patch 
Strand Health Group

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Nuvira Patch

Drug Facts

Active Ingredients

Capsaicin 0.01%

Diclofenac Sodium 1% (NSAID)

Lidocaine 4%

Menthol 5%

Methyl Salicylate 8% (NSAID)

Purpose

Counterirritant

Arthritis Pain Reliever

Topical Anesthetic

Topical Analgesic

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: Diclofenac 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 Diclofenac. Liver damage may occur if you apply (1) more or for a longer time than directed or (2) when using other drugs containing Diclofenac.

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 Diclofenac 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 at 59°F - 77°F with seal tightly sealed.
  • 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

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NUVIRA PATCH 
diclofenac 1%, lidocaine 4%, menthol 5%, capsaicin 0.01%, methyl salicylate 8% patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 83295-4142
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.04 g  in 1 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.08 g  in 1 g
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1) DICLOFENAC SODIUM0.01 g  in 1 g
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0001 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 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: 83295-4142-35 in 1 POUCH03/16/202306/29/2023
11000 g in 1 PATCH; Type 0: Not a Combination Product
2NDC: 83295-4142-16 in 1 BOX03/16/202306/29/2023
25 in 1 POUCH
21000 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/16/202306/29/2023
Labeler - Strand Health Group (118929144)

Revised: 6/2023
 

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