EZ-Relief by Primary Pharmaceuticals, Inc. EZ-Relief

EZ-Relief by

Drug Labeling and Warnings

EZ-Relief by is a Otc medication manufactured, distributed, or labeled by Primary Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EZ-RELIEF- camphor, lidocaine, and methyl salicylate patch 
Primary Pharmaceuticals, Inc.

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.

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EZ-Relief

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)

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

Original Manufacturer

Terrain Pharmaceuticals

Reno, NV 89501

TerrainRx.com

877-985-8377

Distributed by:

Primary Pharmaceuticals, Inc.

Ocean Springs MS 39564

Principal Display Panel

label

EZ-RELIEF 
camphor, lidocaine, and methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 72275-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE2.5 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 SALICYLATE4 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
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)  
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 72275-008-155 in 1 BOX11/30/202007/28/2023
13 in 1 POUCH
18650 mg in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/30/202007/28/2023
Labeler - Primary Pharmaceuticals, Inc. (066126126)

Revised: 7/2023