VIVA Patch: Package Insert and Label Information

VIVA PATCH- lidocaine, camphor (natural) and methyl salicylate patch
Terrain Pharmaceuticals

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.

DRUG FACTS

DRUG FACTS

Active Ingredient

Camphor 2%

Purpose

Topical Analgesic

Active Ingredient

Lidocaine 2.5%

Purpose

Topical Anesthetic

Active Ingredient

Methyl Salicylate 4%

(NSAID: nonsteroidal anti-inflammatory drug)

Purpose

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

Ad ults, 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)

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

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

VIVAPatch-Box
(click image for full-size original)

NDC 53225-1030-1
VIVA PATCH

SOOTHING PAIN RELIEF

LIDOCAINE — METHYL SALICYATE — CAMPHOR

  • Reduced Scent
  • Flexible & Form Fitting
  • Deep Penetrating
  • Fast Acting

GET BACK TO LIFE TM

15 Patches

VIVA PATCH
camphor, lidocaine, and methyl salicylate patch
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:53225-1030
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE (LIDOCAINE) LIDOCAINE 2.5 mg in 100 mg
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 2 mg in 100 mg
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 4 mg in 100 mg
Inactive Ingredients
Ingredient Name Strength
NONOXYNOL-30
POLYACRYLIC ACID (250000 MW)
ACRYLIC ACID
POLYSORBATE 80
SORBITAN SESQUIOLEATE
STARCH, CORN
TALC
TARTARIC ACID
TITANIUM DIOXIDE
WATER
ALUMINUM HYDROXIDE
CARBOXYMETHYLCELLULOSE SODIUM
2-ETHYLHEXYL ACRYLATE
GLYCERIN
ISOPROPYL MYRISTATE
METHYL ACRYLATE
SODIUM POLYACRYLATE (8000 MW)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53225-1030-1 5 POUCH in 1 BOX contains a POUCH
1 3 PATCH in 1 POUCH This package is contained within the BOX (53225-1030-1) and contains a PATCH
1 8650 mg in 1 PATCH This package is contained within a POUCH and a BOX (53225-1030-1)
2 NDC:53225-1030-2 1 POUCH in 1 BOX contains a POUCH
2 3 PATCH in 1 POUCH This package is contained within the BOX (53225-1030-2) and contains a PATCH
2 8650 mg in 1 PATCH This package is contained within a POUCH and a BOX (53225-1030-2)
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)

Revised: 10/2021 Terrain Pharmaceuticals

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