Label: MENTHOL PAIN RELIEF GEL-PATCH- menthol patch

  • NDC Code(s): 73557-131-01, 73557-131-02, 73557-131-05, 73557-131-15, view more
    73557-131-16
  • Packager: Shanghai Chuangshi Medical Technology (Group) Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 29, 2024

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

  • Active Ingredient

    Menthol 5.0%

  • Purpose

    Topical Analgesic

  • Uses:

    Temporary relief from minor aches and pains of sore muscles and joints

    associated with: ·arthrits ·backache ·strains ·sprains

  • Warnings

    For external use only

  • Ask a doctor before use if you have:

    Sensitive skin

  • When using this product:

    ·Use only as directed ·Do not bandage tightly or use with heating pad or device ·Avoid contact with eyes or mucous membranes ·Do not apply to wounds or damaged skin ·Do not use with other ointments, creams, sprays, or liniments ·Do not apply to irritated skin ·Store in a cool dry place away from direct sunlight

  • Stop use and ask a doctor if:

    Burning disconfort or excessive skin irritation develops, condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days

  • If pregnant or breast-feeding:

    Ask a health professional before use

  • Keep out of reach of children:

    If accidentally ingested, get medical help or contact a Poison Control Center immediately

  • Directions

    · Adult and Children 12 years of age and older:Clean and dry affected area, partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin and leave in place for up to 8 hours. Use on affected areas not more than 4 times daily. Wash hands with cool water after use.

    · Children under 12 years of age: Consult physician

  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Camellia Sinensis Leaf Extract, Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Edetate Disodium, Glycerin, Hydroxyacetophenone, Kaolin, L-Tartaric Acid, Mineral Oil, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, PVP, Sodium Polyacrylate, Titanium dioxide, Water

  • Questions or Comments:

    1 646-223-0128 ·Lu.FDAmanage@gmail.com

  • STORAGE AND HANDLING

    ·Store in a cool dry place away from direct sunlight

  • PRINCIPAL DISPLAY PANEL

    020516

  • INGREDIENTS AND APPEARANCE
    MENTHOL PAIN RELIEF GEL-PATCH 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73557-131
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    KAOLIN (UNII: 24H4NWX5CO)  
    TARTARIC ACID (UNII: W4888I119H)  
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73557-131-1515 in 1 BOX01/09/202401/16/2024
    1NDC:73557-131-0113 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:73557-131-1615 in 1 BOX01/09/2024
    2NDC:73557-131-0211 g in 1 PATCH; Type 0: Not a Combination Product
    3NDC:73557-131-055 in 1 BOX02/02/2024
    3NDC:73557-131-0211 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01701/09/2024
    Labeler - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
    Registrant - Shanghai Chuangshi Medical Technology (Group) Co., Ltd. (546872672)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Chuangshi Medical Technology (Group) Co., Ltd.546872672manufacture(73557-131) , label(73557-131)