CLM Patch

United States - English - NLM (National Library of Medicine)

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Active ingredient:
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941), METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
Primary Pharmaceuticals, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Topical Analgesic Topical Anesthetic Topical Analgesic Temporarily relieves mild to moderate aches and pains of muscles and joints associated with: • muscle soreness • strains • sprains • arthritis • simple backache • muscle stiffness • bruises • 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
Authorization status:
OTC monograph not final
Authorization number:
72275-002-15

CLM PATCH- 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.

----------

CLM Patch

DRUG FACTS

DRUG FACTS

Active Ingredient

Camphor 2%

Purpos e

Topical Analgesic

Active Ingredient

Lidocaine 2.5%

Purpos e

Topical Anesthetic

Active Ingredient

Methyl Salicylate 4%

(NSAID: nonsteroidal anti-inflammatory drug)

Purpos e

Topical Analgesic

Us es

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

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

Ocean Springs MS 39564

Principal Display Panel

CLM PATCH

camphor, lidocaine, and methyl salicylate patch

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:72275-0 0 2(NDC:53225-10 30 )

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7)

LIDOCAINE

2.5 mg

in 10 0 mg

CAMPHO R ( NATURAL) (UNII: N20 HL7Q9 41) (CAMPHOR (NATURAL) -

UNII:N20 HL7Q9 41)

CAMPHOR

(NATURAL)

2 mg in 10 0 mg

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE 4 mg in 10 0 mg

Inactive Ingredients

Ingredient Name

Stre ng th

ALUMINUM HYDRO XIDE (UNII: 5QB0 T2IUN0 )

Primary Pharmaceuticals, Inc.

CARBO XYMETHYLCELLULO SE SO DIUM (UNII: K6 79 OBS311)

2 -ETHYLHEXYL ACRYLATE (UNII: HR49 R9 S6 XG)

GLYCERIN (UNII: PDC6 A3C0 OX)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

METHYL ACRYLATE (UNII: WC48 7PR9 1H)

SO DIUM PO LYACRYLATE ( 8 0 0 0 MW) (UNII: 28 5CYO341L)

NO NO XYNO L-3 0 (UNII: JJX0 7DG18 8 )

PO LYACRYLIC ACID ( 2 50 0 0 0 MW) (UNII: 9 G2MAD7J6 W)

ACRYLIC ACID (UNII: J9 4PBK7X8 S)

PO LYSO RBATE 8 0 (UNII: 6 OZP39 ZG8 H)

SO RBITAN SESQ UIO LEATE (UNII: 0 W8 RRI5W5A)

STARCH, CO RN (UNII: O8 232NY3SJ)

TALC (UNII: 7SEV7J4R1U)

TARTARIC ACID (UNII: W48 8 8 I119 H)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:72275-0 0 2-15

5 in 1 BOX

0 9 /0 1/20 19

1

3 in 1 POUCH

1

8 6 50 mg in 1 PATCH; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt348

0 9 /0 1/20 19

Labeler -

Primary Pharmaceuticals, Inc. (066126126)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Terrain Pharmaceuticals

0 78 358 750

ma nufa c ture (72275-0 0 2)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Unit Do se, Inc.

36 0 8 0 419 4

re pa c k(72275-0 0 2)

Revised: 9/2019

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