Label: BIOACHES- capsaicin , menthol patch

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 9, 2015

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

  • DESCRIPTION:

    Bioaches Patch contains capsaicin and menthol in a localized dermal delivery system. The capsaicin in Bioaches Patch is a synthetic equivalent of the naturally occurring compound found in chili peppers. Capsaicin is soluble in alcohol, acetone, and ethyl acetate and very slightly soluble in water. The menthol is slightly soluble in water.
    Bioaches Patch is a single-use patch stored in a foil pouch. Each Bioaches Patch is 7.6 cm x 12.7 cm (97 cm²) and consists of a polyester backing film coated with a drug-containing silicone adhesive mixture, and covered with a removable polyester release liner.
    The empirical formula for capsaicin is C H NO , with a molecular weight of 305.42. The chemical compound capsaicin [(E)-8-methyl-N-vanillyl-6-nonenamide] is an activating ligand for transient receptor potential vanilloid 1 receptor (TRPV1) and it has the following structure:

    image description

    The empirical formula for menthol is C H O, with a molecular weight of 156.27. The chemical compound menthol [(1R,2S,5R)-2-isopropyl-5-methylcyclohexanol ] is an activating ligand for transient receptor potential cation channel subfamily M member 8 (TRPM8). It has the following structure:

    image description

    Each Bioaches Patch contains 0.0375% capsaicin (0.0375 grams of capsaicin per patch) and 5.00% menthol (5 grams of menthol per patch). 

  • INDICATIONS AND USAGE

    Bioaches Patch is indicated for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.
    Bioaches Patch is an external analgesic/counterirritant.

  • CONTRAINDICATIONS

    Bioaches Patch is contraindicated for those patients with a history of hypersensitivity to any of the components of the preparation.

  • WARNINGS

    • For external use only.
    • Use only as directed.
    • Avoid contact with eyes and mucous membranes.
    • Do not cover with bandage.
    • Do not use on wounds or damaged skin.
    • Consult physician for children under 12.
    • Do not use if you are allergic to Menthol.
    • Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days or rash, itching or excessive skin irritation occurs.
    • KEEP OUT OF REACH OF CHILDREN

  • DOSAGE AND ADMINISTRATION

    Bioaches patch contains 0.0375% capsaicin and 5.00% menthol

    Instructions for Use

    Clean and dry affected area
    Tear open pouch. Unseal bag and remove patch
    Remove protective film and apply directly to area of pain
    Apply to affected area not more than 3 times daily
    Wash hands with soap after applying patch
    Reseal pouch containing unused patches


    Directions

     Adults and children 12 years and over 
    •  apply to affected area
    •  change patch 1 to 2 times daily
     Children under 12 years 

    • consult physician before use

  • INACTIVE INGREDIENT

    Inactive Components: Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Diazolidinyl Urea, EDTA Disodium Salt, Glycerin, lodopropynyl Butyl carbamate, Methylparaben, Polysorbate 80, Propylparaben. Sodium Polyacrylate and Water.

  • HOW SUPPLIED

    Bioaches patch is supplied as 

    Box of 15 patchs: 3 pouches each containing 5 patches

    Box of 1 patch: 1 Pouch in one Box

    Box of 30 patches: 6 pouches each containing 5 patches.

    Storage: Store below 25°C. Avoid direct sunlight.

  • SPL UNCLASSIFIED SECTION

    Rx only

  • Packaging

    image description

  • INGREDIENTS AND APPEARANCE
    BIOACHES 
    capsaicin , menthol patch
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69490-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0375 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69490-020-153 in 1 BOX
    15 in 1 POUCH
    2NDC:69490-020-011 in 1 BOX
    21 in 1 POUCH
    3NDC:69490-020-306 in 1 BOX
    35 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/10/2015
    Labeler - BIO-SANTEE CHEM (014672538)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Bangli Medical Products Co., Ltd421295875manufacture(69490-020)