Label: MEDICATED PAIN RELIEF PATCHES- camphor, menthol, methyl salicylate patch

  • NDC Code(s): 63868-124-20, 63868-124-60
  • Packager: QUALITY CHOICE (Chain Drug Marketing Association)
  • Category: HUMAN OTC DRUG LABEL

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 Label Information

Updated September 14, 2017

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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:

    • On wounds or damaged skin
    • With a heating pad
    • If you are allergic to any ingredients of this product
  • When using this product

    • Use only as directed
    • Avoid contact with eyes, mucous membranes or rashes
    • Do not bandage tighly
    • Do not use at the same time as other topical analgesics
    • Dispose of used patch in manner that keeps product away from childrens and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
  • Stop use and consult a doctor

    • If rash, itching or excessive skin irritation develops
    • If condition worsens
    • if symptoms last more than 7 days or clear up and occur again with a few days

  • 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.

  • Questions or Comments

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

  • Pain Relief Patch Label

    Box of 60


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

    Distributed by C.D.M.A., Inc.

    43157 W. Nine Mile

    Novi, MI 48375

    Made in China

  • INGREDIENTS AND APPEARANCE
    MEDICATED PAIN RELIEF PATCHES 
    camphor, menthol, methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-124
    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:63868-124-6060 in 1 BOX09/01/2017
    19 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:63868-124-2020 in 1 BOX09/01/2017
    29 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 finalpart34809/01/2017
    Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(63868-124)