Label: LANLIJEN MENTHOL PAIN RELIEF- menthol patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 13, 2022

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  • Active ingredient

    Menthol 5.0% w/w ...... Purpose: Topical Analgesic

  • Purpose

    Topical Analgesic

  • Uses

    Temporary relief from minor aches and pains of sore muscles and joints associated with arthritic, backache, strains and sprains

  • Warnings

    For external use only

    Flammable, Keep away from excessive heat or open flame

    Ask a doctor before use if you have Sensitive Skin

    Stop use and ask a doctor if burning discomfort or excessive skin irritation develops, conditions worsen, or symptoms persist for more than 7 days, or clear up and reoccur within a few days

  • ASK DOCTOR

    Ask a doctor before use if you have Sensitive Skin

    Stop use and ask a doctor if burning discomfort or excessive skin irritation develops, conditions worsen, or symptoms persist for more than 7 days, or clear up and reoccur within a few days

  • STOP USE

    Stop use and ask a doctor if burning discomfort or excessive skin irritation develops, conditions worsen, or symptoms persist for more than 7 days, or clear up and reoccur within a few days

  • When using this product

    Avoid contact with eyes or mucous membranes • Do not use with other creams, sprays, ointments, or liniments • Do not apply to wounds or damaged skin • Do not apply to irritated skin or if excessive irritation develops • Do not use with heating pad or device • Store in a cool dry place • Do not bandage • Use only as directed • Wash hands after use with cool water.

  • DO NOT USE

    • Do not use with other creams, sprays, ointments, or liniments • Do not apply to wounds or damaged skin • Do not apply to irritated skin or if excessive irritation develops • Do not use with heating pad or device

  • STORAGE AND HANDLING

    • Store in a cool dry place

  • 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

    Adults and children 12 years of age and older, 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. Clean and dry afected areas, partially peel back protective film and apply exposed patch to site of pain.

    Children under 12 years of age, Consult physician

  • ASK DOCTOR/PHARMACIST

    Children under 12 years of age, Consult physician

  • Inactive Ingredients

    Aloe barbadensis leaf extract, Arnica montana flower extract, Benzalkonium chloride, Boswellia carterii resin extract, Camellia sinensis leaf extract, Carboxymethylcellulose sodium, Dihydroxyaluminum aminoacetate, Edetate disodium, Glycerin, Kaolin, Lauralkonium chloride, L-Tartaric acid, Mineral oil, Petrolatum, PVP, Polyacrylic acid, Polysorbate 80, Propylene glycol, Sodium polyacrylate, Titanium dioxide, Water

  • Questions or Comments

    86-513-89072216

    E-mail:info@lanlijen.com
    www.lanlijen.com
    Tel:86-513-89072216

  • OTHER SAFETY INFORMATION

    No Animal Testing, No NSAIDs, lbuprofen, Aspirin or Salicylate

  • Package label. Principal display panel

    Container PackageBox Labeling

  • INGREDIENTS AND APPEARANCE
    LANLIJEN MENTHOL PAIN RELIEF 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83050-251
    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
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    KAOLIN (UNII: 24H4NWX5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FRANKINCENSE (UNII: R9XLF1R1WM)  
    BENZODODECINIUM CHLORIDE (UNII: Y5A751G47H)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TARTARIC ACID (UNII: W4888I119H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83050-251-055 in 1 BOX12/15/2022
    1NDC:83050-251-019 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/15/2022
    Labeler - Jiangsu Chaben Medical Healthcare Technology Co.,Ltd (615936219)
    Registrant - Jiangsu Chaben Medical Healthcare Technology Co.,Ltd (615936219)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Chuangshi Medical Technology (Group) Co., Ltd.546872672manufacture(83050-251)
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