Label: PAIN RELIEVING patch

  • NDC Code(s): 85009-001-01, 85009-001-02
  • Packager: Changsha Yunhan Hechuang E-Commerce Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 3, 2024

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

  • ACTIVE INGREDIENT

    Camphor 80mg/patch

    Menthol 24mg/patch

    Capsicum Extract 16mg/patch

  • PURPOSE

    Topocal Analgesic

  • INDICATIONS & USAGE

    Uses

    For temporary relief of pains

  • WARNINGS

    Warnings FOR EXTERNAL USE ONLY

  • DO NOT USE

    · Do not use wit a heating pad or apply extecnal heat

    · Do not use 1 hour prior to bathing or within 30 minutes after bathing

  • WHEN USING

    When using this product

    · Use only as directed

    · Do not get into eyes or on mucous membranes

    · Do not apply to wounds,damaged or imitated skin

    · Do not bandage or cover with any type of wrap except clothing

    · Do not use wit a heating pad or apply extecnal heat

    · Do not use 1 hour prior to bathing or within 30 minutes after bathing

  • STOP USE

    Stop use and ask a doctor if

    · Condition worsens

    · Severe skin irritation occurs

    · Pain persists for more than 7 days

    · Symptoms clear up and occur again within a few days

    If pregnant or breast-feeding,or if you have sensitive skin,ask a healthcare professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.lf swallowed,get medical helpor contact Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    · Adults and children 12 years and over apply to affected area;change patch 1 to 2 times daily

    · Children under 12 years,consult doctor before use

    · How to apply:

    · Clean and dry affected area

    · Cut open pouch 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

  • STORAGE AND HANDLING

    Other Information This product may cause allergic reaction on some individuals.Store in cool dry place away from direct sunlight.

  • INACTIVE INGREDIENT

    Inactive Ingredients:Aluminium glycinate,eucalyptus oil,glycerin,hydrotalcite,kaolin,mentha oil,polysorbate 80,polyacrylic acid solution,propylene glycol,sodium carboxymethylcellulose,sodium polyacrylate,sorbitol solution,water

  • PRINCIPAL DISPLAY PANEL

    85009-001-0185009-001-02

  • INGREDIENTS AND APPEARANCE
    PAIN RELIEVING 
    pain relieving patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85009-001
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL24 mg  in 100 
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)80 mg  in 100 
    CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM16 mg  in 100 
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    SORBITOL SOLUTION (UNII: 8KW3E207O2)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    KAOLIN (UNII: 24H4NWX5CO)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
    WATER (UNII: 059QF0KO0R)  
    CARBOMER (UNII: 0A5MM307FC)  
    HYDROTALCITE (UNII: 17432CG1KU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85009-001-0150 in 1 BOX; Type 0: Not a Combination Product12/03/2024
    2NDC:85009-001-0250 in 1 BOX; Type 0: Not a Combination Product12/03/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01712/03/2024
    Labeler - Changsha Yunhan Hechuang E-Commerce Co., Ltd. (453545466)
    Establishment
    NameAddressID/FEIBusiness Operations
    Changsha Yunhan Hechuang E-Commerce Co., Ltd.453545466manufacture(85009-001)