Label: PAIN RELIEFPATCHES PATCHES- dl-camphor l-menthol methyl salicylate patch

  • 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 August 15, 2012

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

  • ACTIVE INGREDIENT

    Active ingredients

    For External Use Only

    DL-Camphor 1.2%.......................................................................................................................................Topical analgesic

    L-Menthol 4.0%..........................................................................................................................................Topical analgesic

    Methyl Salicylate 6.3%................................................................................................................................Topical analgesic

  • PURPOSE

    Uses

    For temporary relief of minor aches and pains associated with:

    Arthritis

    Backaches

    Sprains

    Strains

    Bruises

  • WARNINGS

    Warnings

    For External Use Only

  • INDICATIONS & USAGE

    Do not use

    other than as directed on wounds, damaged or irritated skin in combination with other external analgesic

    products, ointments, creams or with a heating pad. in contact with eyes or mucous membranes. if you are

    allergic to any ingredient in this product. if you have a history of allergic reactions to this or similar products

  • STOP USE

    Stop Use and ask a doctor if

    rash, itching or excessive skin irritation develops

    condition worsens

    symptoms persist for more than 7 days

    if symptoms subside and then reappear within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 12 years of age and over: Clean and dry the affected area. Remove patch from film backing. Adhere

    to area for no more than 8 hours at a time, not more than 3 times per day, and for no more than 7 days continuously.

    Children under 12 years of age: Consult a doctor before use.

  • STORAGE AND HANDLING

    Other information

    Store in a cool dry place. Avoid direct sunlight.

  • INACTIVE INGREDIENT

    Inactive ingredients Ammonium Stearate, Calcium Carbonate, Glyceryl Abietate, Isopropyl Myristate, Natural

    Rubber, Polybutene, Polyisobutylene, Propylene Carbonate, Styrene Copolymer, YS Resin, Zinc Oxide

  • PRINCIPAL DISPLAY PANEL

    image of label

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEFPATCHES   PATCHES
    dl-camphor l-menthol methyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53043-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.2 mL  in 100 mL
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL4 mL  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE6.3 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    AMMONIUM STEARATE (UNII: 37899330TZ)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    GLYCERYL ABIETATE (UNII: 2F22LY70Q1)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)  
    POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    STYRENE (UNII: 44LJ2U959V)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53043-001-0120 in 1 CARTON
    124 mL in 1 PATCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2012
    Labeler - Shanghai Aquagel Bio-Plymer Co., Ltd (421199544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Aquagel Bio-Plymer Co., Ltd421199544manufacture(53043-001)