Nuvira by Advanced Rx Pharmacy of Tennessee, LLC Nuvira Patch

Nuvira by

Drug Labeling and Warnings

Nuvira by is a Otc medication manufactured, distributed, or labeled by Advanced Rx Pharmacy of Tennessee, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

NUVIRA- capsaicin 0.025%, menthol 10%, methyl nicotinate 0.25%, methyl salicylate 10% patch 
Advanced Rx Pharmacy of Tennessee, LLC

----------

Nuvira Patch

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 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

• 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 
capsaicin 0.025%, menthol 10%, methyl nicotinate 0.25%, methyl salicylate 10% patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80425-0356(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: 80425-0356-1	5 in 1 POUCH	10/16/2023
1		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	505G(a)(3)	10/16/2023	03/31/2024

Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)

Establishment
Name	Address	ID/FEI	Business Operations
Advanced Rx Pharmacy of Tennessee, LLC		117023142	repack(80425-0356)

Revised: 3/2024

Document Id: 137b7024-b667-9287-e063-6394a90aa6fe

34390-5

Set id: 087c4fcd-2e74-1b31-e063-6394a90a1ef6

Version: 2

Effective Time: 20240312