Label: BIOACHES- capsaicin , menthol patch
-
Contains inactivated NDC Code(s)
NDC Code(s): 69490-020-01, 69490-020-15, 69490-020-30 - Packager: BIO-SANTEE CHEM
- 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
-
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: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:
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
- CONTRAINDICATIONS
-
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
DirectionsAdults 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
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- Packaging
-
INGREDIENTS AND APPEARANCE
BIOACHES
capsaicin , menthol patchProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69490-020 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.0375 g MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69490-020-15 3 in 1 BOX 1 5 in 1 POUCH 2 NDC:69490-020-01 1 in 1 BOX 2 1 in 1 POUCH 3 NDC:69490-020-30 6 in 1 BOX 3 5 in 1 POUCH Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/10/2015 Labeler - BIO-SANTEE CHEM (014672538) Establishment Name Address ID/FEI Business Operations Zhejiang Bangli Medical Products Co., Ltd 421295875 manufacture(69490-020)