PAIN RELIEF PATCH (MENTHOL,CAPSAICIN,MENTHYL SALICYLATE) PATCH [HANGZHOU JUJIU SCIENCE & BIOTECHNOLOGY CO.,LTD.]

PAIN RELIEF PATCH (MENTHOL,CAPSAICIN,MENTHYL SALICYLATE) PATCH [HANGZHOU JUJIU SCIENCE & BIOTECHNOLOGY CO.,LTD.]
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NDC 69963-001-01
Set ID 4155cff9-27ca-448e-af85-c1bdfe26f744
Category HUMAN OTC DRUG LABEL
Packager Hangzhou Jujiu Science & Biotechnology Co.,Ltd.
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredient

    Menthyl salicylate 5.00% 
    Menthol 5.00% 
    Capsaicin 0.025% 

  • Purpose

    Topical analgesic

  • Use

     Arthritis
     simple backache
     strains
     sprains
     bursitis
     tendonitis
     bruises
     cramps

  • Warnning

    Do not apply wounds or damaged skin.
    Do not bandage this product or cover with anything other than light clothing
    Avoid contact with eyes or mucous membranes.
    Ask a doctor or pharmacist before use if you are
     allergic to salicylates
     taking anticoagulant medications .
    When using this product
     For external use only, to relieve the temporary pain.
    The application of external heat, such as a heating pad may result in excessive skin irritation or skin burn.
    Stop use and ask a doctor if
     rash, irritation, excessive redness, burning or discomfort of the skin develop.
     condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product with any other heating or cooling device or with other external analgesic products.

    Keep out of reach of children, Children 12 years of age and under should only use this product upon the advice of a healthcare practitioner.

  • Directions

     Adults: Apply Pain relief patch to the affected area not more than 3 to 4 times daily.
     For children under 12 years of age, consult your health care practitioner.
     Open pouch and remove patch.
     If desired, cut patch to size.
     Peel off protective film and apply sticky side to desired area.
     Remove patch before applying a new one.
     Dispose of patch in waste receptacle.
     If condition worsens, of if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a healthcare practitioner.

  • Inactive Ingredients

    Aluminium glycinate, Ethylene Diamine Tetraacetic Acid, Polysorbate 80, Titanium dioxide, Purified water, Tartaric acid, Glycerin, Sodium polyacrylate, Carbomer, Sodium carboxymethyl cellulose

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEF PATCH 
    menthol,capsaicin,menthyl salicylate patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69963-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    MENTHYL SALICYLATE, (+/-)- (UNII: 43XOA705ZD) (SALICYLIC ACID - UNII:O414PZ4LPZ) MENTHYL SALICYLATE, (+/-)-5 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALUMINIUM TRIGLYCINATE (UNII: 5TLG1CL557) 0.025 g  in 100 g
    DIAMINOHYDROXYPROPANETETRAACETIC ACID (UNII: 949B9ZMO7M) 0.025 g  in 100 g
    POLYSORBATE 80 (UNII: 6OZP39ZG8H) 0.025 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) 0.025 g  in 100 g
    WATER (UNII: 059QF0KO0R) 0.025 g  in 100 g
    TARTARIC ACID (UNII: W4888I119H) 0.025 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.025 g  in 100 g
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) 0.025 g  in 100 g
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.025 g  in 100 g
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) 0.025 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69963-001-015 in 1 POUCH01/08/2018
    10.5 g in 1 KIT; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/10/2015
    Labeler - Hangzhou Jujiu Science & Biotechnology Co.,Ltd. (543207110)
    Registrant - Hangzhou Jujiu Science & Biotechnology Co.,Ltd. (543207110)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Jujiu Science & Biotechnology Co.,Ltd.543207110manufacture(69963-001)

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