Label: HERBOJOINT-US cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 20, 2021

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

  • ACTIVE INGREDIENT

    Active Ingredient                     Purpose
    Menthol 7.0%                          Topical Analgesic Cream

  • PURPOSE

    Purpose:
    Penetrating Pain Relief-Arthritis

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor aches and pains of muscles and joint associated with arthritis

  • WARNINGS

    Warnings

    • For external use only.
    • Avoid contact with the eyes.
    • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult physician.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of ages: consult a physician.
  • STORAGE AND HANDLING

    Other information

    • Store in a cool place.
    • Protect from freezing and excessive heat.
  • INACTIVE INGREDIENT

    Inactive ingredients: 

    Water, Propanediol, Cymbopogon Citratus Leaf Oil, Cetearyl Alcohol, Glyceryl Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Triethanolamine, Glycerin, Hedychium Spicatum Extract, Zanthoxylum Alatum Fruit Extract, Gluconolactone, Sodium Benzoate, Carbomer, Ceteth-10, Steareth-30.

  • HOW SUPPLIED

    Distributed By:
    Bordoloi Biotech, LLC., Bridgewater, NJ 08807

    www.HerboJoint.com
    Made in India

  • PRINCIPAL DISPLAY PANEL

    cartonlabeltubelabel

  • INGREDIENTS AND APPEARANCE
    HERBOJOINT-US 
    herbojoint-us cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73673-113
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL70 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    JOJOBA OIL (UNII: 724GKU717M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEDYCHIUM SPICATUM ROOT (UNII: 1831B6Y350)  
    ZANTHOXYLUM ARMATUM FRUIT (UNII: ER3FV125H7)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETETH-10 (UNII: LF9X1PN3XJ)  
    STEARETH-30 (UNII: 5776GCL1DG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73673-113-131 in 1 CARTON07/20/2021
    174 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/20/2021
    Labeler - Bordoloi Biotech, LLC. (012182964)
    Registrant - Bordoloi Biotech, LLC. (012182964)
    Establishment
    NameAddressID/FEIBusiness Operations
    MS LAB INDIA915206683manufacture(73673-113)