Label: LEADER MEDICATED RELIEF PATCH (camphor- synthetic levomenthol salicylic acid patch

  • NDC Code(s): 70000-0206-1, 70000-0206-2
  • Packager: CARDINAL HEALTH, INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 December 17, 2016

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active IngredientPurpose
     DL-Camphor 1.2% Topical Analgesic
     L-Menthol 5.7% Topical Analgesic
     Methyl Salicylate 6.3% Topical Analgesic

  • INACTIVE INGREDIENT

    Glyceryl Hydrogenated Rosinate, Styrene/Isoprene Copolymer, Hydrated Silica, Mineral Oil, Polyisobutylene (1300 MW), PEG-400, Zinc Oxide, Ys Resin.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    Temporary relief of aches and pains associated with arthritis, simple backache, strains, sprains, bruises.

  • WARNINGS

    For External Use Only

  • DOSAGE & ADMINISTRATION

    Adults and children over 12 years: clean and dry affected area. Carefully remove backing from patch. Apply sticky side of patch to affected area.

    Wear one patch up to 8 hours. Repeat as necessary, no more than 4 times daily, no more than 7 consecutive days.

    Children 12 years or younger, consult a physician.

  • PURPOSE

    Topical Analgesic

  • When using this product:

    • Use only as directed
    • Avoid contact with eyes, mucous membranes or skin rashes.
  • Do not use

    • On wounds or damaged skin
    • If you are allergic to aspirin or salicylates or with other external analgesic products
    • With a heating pad
    • If you are allergic to any ingredients in this product.   
  • top 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.
  • Storage and Care

    Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

  • Medicated Relief

    Label Image
  • INGREDIENTS AND APPEARANCE
    LEADER MEDICATED RELIEF PATCH 
    camphor (synthetic) levomenthol salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0206
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.2 
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL5.7 
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE6.3 
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    STYRENE (UNII: 44LJ2U959V)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYISOBUTYLENE (1100000 MW) (UNII: FLT10CH37X)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70000-0206-120 in 1 BOX12/01/2016
    11 in 1 POUCH; Type 0: Not a Combination Product
    2NDC:70000-0206-240 in 1 BOX12/01/2016
    21 in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/01/2016
    Labeler - CARDINAL HEALTH, INC (097537435)
    Establishment
    NameAddressID/FEIBusiness Operations
    Foshan Aqua Gel Biotech Co., Ltd.529128763manufacture(70000-0206)