![VIVA PATCH (CAMPHOR, LIDOCAINE, AND METHYL SALICYLATE) PATCH [TERRAIN PHARMACEUTICALS]](https://medic.hrt.org//dailymed/images/357b7a59-29ac-61e2-e054-00144ff88e88/VIVAPatch-Box.jpg)
| NDC | 53225-1030-1, 53225-1030-2 |
| Set ID | 357b7a59-29ac-61e2-e054-00144ff88e88 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Terrain Pharmaceuticals |
| Generic Name | |
| Product Class | Amide Local Anesthetic, Antiarrhythmic |
| Product Number | |
| Application Number | PART348 |
- DRUG FACTS
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Active Ingredient
- Purpose
- Uses
-
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
- Directions
-
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
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
- Principal Display Panel
-
INGREDIENTS AND APPEARANCE
VIVA PATCH
camphor, lidocaine, and methyl salicylate patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53225-1030 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 2.5 mg in 100 mg CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL) 2 mg in 100 mg METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 4 mg in 100 mg Inactive Ingredients Ingredient Name Strength NONOXYNOL-30 (UNII: JJX07DG188) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) ACRYLIC ACID (UNII: J94PBK7X8S) POLYSORBATE 80 (UNII: 6OZP39ZG8H) SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) WATER (UNII: 059QF0KO0R) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG) GLYCERIN (UNII: PDC6A3C0OX) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) METHYL ACRYLATE (UNII: WC487PR91H) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53225-1030-1 5 in 1 BOX 08/31/2016 1 3 in 1 POUCH 1 8650 mg in 1 PATCH; Type 0: Not a Combination Product 2 NDC:53225-1030-2 1 in 1 BOX 08/31/2016 12/16/2019 2 3 in 1 POUCH 2 8650 mg 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 not final part348 08/31/2016 Labeler - Terrain Pharmaceuticals (078358750)
