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Pain ReliefPatches (Shanghai Aquagel Bio-Plymer Co., Ltd)

Available Formats

Dosage Form Package Information Links
PATCH 20 PATCH in 1 CARTON (53043-001-01) > 24 mL in 1 PATCH Label Information

Complete Pain ReliefPatches Information

  • 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


  • INGREDIENTS AND APPEARANCE
    PAIN RELIEFPATCHES   PATCHES
    dl-camphor l-menthol methyl salicylate patch
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:53043-001
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 1.2 mL  in 100 mL
    LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 4 mL  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 6.3 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53043-001-01 20 in 1 CARTON
    1 24 mL in 1 PATCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 10/01/2012
    Labeler - Shanghai Aquagel Bio-Plymer Co., Ltd (421199544)
    Establishment
    Name Address ID/FEI Business Operations
    Shanghai Aquagel Bio-Plymer Co., Ltd 421199544 manufacture(53043-001)