PAIN RELIEF PATCHES- camphor, menthol, methyl salicylate patch 
Chain Drug Consortium, LLC

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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Medicated Pain Relief Patch Topical Analgesic

Active Ingredients

Active Ingredients Purpose

Camphor 3.1% ......................Topical Analgesic

Menthol 6.0% .......................Topical Analgesic

Methyl Salicylate 10.0% ........Topical Analgesic

For External Use Only

Allergy alert: If prone to allergic reaction from asprin or salicylates, consult a doctor before use

Do not use:

When using this product

QUESTIONS

Customer Care Help Line
248-449-9300
www.qualitychoice.com

Stop use and consult a doctor

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Uses

For temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains, and bruises.

Directions

Adults and children 12 years of age and over: Clean and dry affected area. Remove patch from film, apply to affected area not more than 3 to 4 times daily. Remove patch from the skin after at most, 8-hour application.

Children under 12 years of age: consult physician.

Inactive Ingredients

Hydrogenated Poly, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petroleum, Styrene / Isoprene Copolymer

Indication and Usage

For temporary relief of minor aches and pains.

Pain Relief Patch Label

Box of 60


Other Information: Store in clean, dy place outside of direct sunlight. Protect from excessive moisture.

PAIN RELIEF PATCHES 
camphor, menthol, methyl salicylate patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-071
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)3.1 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL6 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
LIQUID PETROLEUM (UNII: 6ZAE7X688J)  
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
Product Characteristics
Color    Score    
ShapeSQUARESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-071-6060 in 1 BOX06/01/2017
19 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/2017
Labeler - Chain Drug Consortium, LLC (101668460)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(68016-071)

Revised: 10/2017
Document Id: 3251b046-7019-44f4-b84d-d848286bf4c5
Set id: 671bc765-1196-4b86-92ee-8aad040713eb
Version: 2
Effective Time: 20171001
 
Chain Drug Consortium, LLC