Label: SOOTHING PATCH patch

  • NDC Code(s): 83822-002-01, 83822-002-02, 83822-002-03, 83822-002-04, view more
    83822-002-05, 83822-002-06, 83822-002-07, 83822-002-08, 83822-002-09
  • Packager: Fuzhou Ayimong Trading Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 25, 2024

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  • Active Ingredient

    Borneol 5%

  • Purpose

    Relief the pain.

  • Use

    Used for rheumatic pain, joint pain, low back pain,neuralgia. miscle aches, sprains, and contusions.

  • Warnings

    For external use only.

  • Do not use

    Do not use if there are open wounds on the skin or children.

  • When Using

    Please do not engage in strenuous activities while using this product.

  • Stop Use

    Use time does not exceed 8 hours

  • Keep Oot Of Reach Of Children

    Please place this product in a locker above im away from children.

  • Directions

    Before use, please clean the skin of the affectedarea, peel off the protective film, and apply thispatch directly to the affected area.

  • Other information

    This product may cause occasional skin allergies. Ifyou find erythema or edema caused by skin irritationduring use, you should stop using it imediately.The erythema and edema will generally disappear ontheir own. If necessary, you can apply hormone drugsto the skin allergy area for treatment.

  • Inactive ingredients

    Mentha Arvensis Extract, Artemisia Argyi Leaf Extract, Cinnamomum Camphora Linaloolifera Bark/Leaf/Wood Oil, Carthamus Tinctorius (Safflower) Flower Extract,(Cinnamomum Cassia/Magnolia Officinalis) Bark/(Alpinia Officinarum/Angelica Gigas) Root Extract

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    SOOTHING PATCH 
    soothing patch patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83822-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X) BORNEOL5 g  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    ARTEMISIA ARGYI LEAF (UNII: 2JYC99Q0WZ)  
    MENTHOL (UNII: L7T10EIP3A)  
    CINNAMOMUM CAMPHORA WHOLE (UNII: 0B27814T7X)  
    CINNAMOMUM CASSIA TWIG (UNII: 4UD6VQR2UP)  
    SAFFLOWER (UNII: 4VBL71TY4Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83822-002-0110 in 1 BAG; Type 0: Not a Combination Product02/26/2024
    2NDC:83822-002-0212 in 1 BAG; Type 0: Not a Combination Product02/26/2024
    3NDC:83822-002-0315 in 1 BAG; Type 0: Not a Combination Product02/26/2024
    4NDC:83822-002-0424 in 1 BAG; Type 0: Not a Combination Product02/26/2024
    5NDC:83822-002-0526 in 1 BAG; Type 0: Not a Combination Product02/26/2024
    6NDC:83822-002-0630 in 1 BAG; Type 0: Not a Combination Product02/26/2024
    7NDC:83822-002-0748 in 1 BAG; Type 0: Not a Combination Product02/26/2024
    8NDC:83822-002-0860 in 1 BAG; Type 0: Not a Combination Product02/26/2024
    9NDC:83822-002-0972 in 1 BAG; Type 0: Not a Combination Product02/26/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/26/2024
    Labeler - Fuzhou Ayimong Trading Co., Ltd. (416068159)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fuzhou Ayimong Trading Co., Ltd.416068159manufacture(83822-002) , label(83822-002)
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