MLC- camphor, lidocaine, and methyl salicylate kit

MLC by

Drug Labeling and Warnings

MLC by is a Otc medication manufactured, distributed, or labeled by Primary Pharmaceuticals, Inc., Terrain Pharmaceuticals, Unit Dose Solutions, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

SPL UNCLASSIFIED SECTION

Terrain Pharmaceuticals

Reno, NV 89501

TerrainRx.com

877-985-8377

Principal Display Panel

15 Patches

INGREDIENTS AND APPEARANCE

MLC 
camphor, lidocaine, and methyl salicylate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72275-003

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72275-003-15	1 in 1 BOX; Type 0: Not a Combination Product	01/01/2020

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	0 PATCH	1 mg

Part 1 of 1

VIVA PATCH 
camphor, lidocaine, and methyl salicylate patch

Product Information
Item Code (Source)	NDC: 53225-1030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	2.5 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)
METHYL ACRYLATE (UNII: WC487PR91H)
NONOXYNOL-30 (UNII: JJX07DG188)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
ACRYLIC ACID (UNII: J94PBK7X8S)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
STARCH, CORN (UNII: O8232NY3SJ)
TALC (UNII: 7SEV7J4R1U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		5 in 1 BOX
1		3 in 1 POUCH
1		8650 mg in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/31/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	08/10/2016

Labeler - Primary Pharmaceuticals, Inc. (066126126)

Establishment
Name	Address	ID/FEI	Business Operations
Terrain Pharmaceuticals		078358750	manufacture(53225-1030)

Establishment
Name	Address	ID/FEI	Business Operations
Unit Dose Solutions, Inc		360804194	repack(72275-003)