FDA Label for Viva Patch
View Indications, Usage & Precautions
- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- USES
- WARNINGS
- STOMACH BLEEDING WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF
- WHEN USING THIS PRODUCT
- STOP USE AND CONSULT YOUR PHYSICIAN IF
- IF PREGNANT OR BREAST FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- INSTRUCTIONS FOR USE
- OTHER INFORMATION
- INACTIVE INGREDIENT
- OTHER
- PRINCIPAL DISPLAY PANEL
Viva Patch Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Rx Pharmacy Of Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Drug Facts
DRUG FACTS
Active Ingredient
Camphor 2%
Lidocaine 2.5%
Methyl Salicylate 4%
(NSAID: nonsteroidal anti-inflammatory drug)
Purpose
Topical Analgesic
Topical Anesthetic
Topical Analgesic
Uses
Temporarily relieves mild to moderate aches and pains of muscles and joints associated with:
• muscle soreness
• strains
• sprains
• arthritis
• simple backache
• muscle stiffness
• bruises
Warnings
For external use only
Stomach Bleeding Warning
This product contains an NSAID, which may cause stomach bleeding. The chance is small, but higher if you
• are age 60 or older
• have had stomach ulcers or bleeding problems
• take other drugs containing an NSAID (Aspirin, Ibuprofen, Naproxen, or others)
• take a blood thinning (anticoagulant) or steroid drug
• have three or more alcoholic drinks every day while using this product
• take more or for a longer time than directed
Do Not Use
• on the face or rashes; on wounds or damaged skin
• in the eyes, mouth, or other mucous membranes
• on genitals
• with a heating pad
• if allergic to any NSAIDS
• right before or after heart surgery
• any patch from a pouch that has been opened for 7 or more days
Ask A Doctor Before Use If
• you are allergic to topical products
• the stomach bleeding warning applies to you
• you are taking a diuretic
• you have high blood pressure, heart disease, or kidney disease
• you are pregnant
When Using This Product
• wash hands after applying or removing patch
• avoid contact with eyes. If eye contact occurs, rinse thoroughly with water
• the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.
Stop Use And Consult Your Physician If
• stomach pain or upset gets worse or lasts
• rash, irritation, or itching develops
• you feel faint, vomit blood, or have bloody or black stools (these are signs of stomach bleeding)
• condition worsens
If Pregnant Or Breast Feeding,
ask a doctor before use while breast feeding and during the first 6 months of pregnancy. Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.
Keep Out Of Reach Of Children.
If put in mouth, get medical help or contact a Poison Control Center right away. Package not child resistant. Dispose of the used patches by folding sticky ends together.
Directions
Adults, or children over the age of 12:
• Apply patch to affected area 1 to 2 times daily or as directed.
Instructions For Use
• clean and dry affected area
• open pouch and remove one patch
• remove protective film from patch
• apply one patch to the affected area of pain and leave in place for 8 to 12 hours
• if pain lasts after using the first patch, a second patch may be applied for up to another 8 to 12 hours
• only use one patch at a time
• do not use more than 2 patches per day
• wash hands with soap and water after applying or removing patch
• reseal pouch containing unused patches immediately after each use
Children under 12 years of age: Do not use
Other Information
• some individuals may not experience pain relief until several minutes or hours after applying the patch
• store in a cool, dry place
• protect product from excessive moisture or sunlight
• store at 67-77°F (19-25°C)
Inactive Ingredient
Acrylic Acid, Aluminum Hydroxide, Carmellose Sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxynol-30, Polyacrylic Acid, Polysorbate 80, Sodium Polyacrylate, Sorbitan Sesquioleate, Starch, Talc, Tartaric Acid, Titanium Dioxide, Water
Other
Terrain Pharmaceuticals
Reno, NV 89501
TerrainRx.com
877-985-8377
Get Back to Life TM
VIVAPatch.com
Engineered in Reno-Tahoe
Assembled in China
Lot Number:
Exp Date:
Principal Display Panel
VIVA PATCH
SOOTHING PAIN RELIEF
LIDOCAINE - METHYL SALICYATE - CAMPHOR
- Reduced Scent
- Flexible & Form Fitting
- Deep Penetrating
- Fast Acting
15 Patches
* Please review the disclaimer below.