Label: DOCTORRELIEF- menthol patch

  • 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 March 27, 2018

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  • Actives

    Active ingredients Purpose
    Menthol 50 mg patch............................................Topical analagesic

  • PURPOSE

    Topical analgesic

  • Indication 

    Uses
    Temporary relief minor aches and pains of muscles and joints associated with:
    ■Arthritis ■Bruises ■Simple backache ■Strains ■Sprains

  • Warnings

    For external use only
    When using this product:
    ■ Use only as directed
    ■ Avoid contact with eyes ,mucous membranes or rashes
    ■ Do not apply to broken, wounded or damaged skin
    ■ Do not bandage or cover with any type of wrap except clothing
    ■ Do not use with a heating pad or apply external heat
    ■ Discontinue use at least 1 hour before a bath or shower and do not use immediately after a bath or shower

  • Questons

    Stop use and ask a doctor if
    ■ Rash, itching or excessive skin irritation develops
    ■ Condition worsens or does not improve after regular use
    ■ Symptoms persist for more than 7 days or clear up and occur again within a few days

  • OTC-Keep out of reach of children

    **Keep out of reach of children**
    If swallowed, get medical help or contact a Poison Control Center immediately

  • Dosages

    Directions
    Adult and children 12 years of age and over
    ■ Clean and dry affected area
    ■ Open pouch and remove patch. If desired, cut patch to size
    ■ Peel off protective backing and apply sticky side to affected area
    ■ Apply to affected area not more than 3 times daily
    ■ Wash hands with soap after applying patch
    Children under 12 years of age
    ■ Consult a doctor

  • Warning and Precautions

    • Do not apply on Ulcerative or suppurative skin area
    • Not be used by during pregnancy
    • This product may cause allergic reaction in some individuals.
  • Ask Doctor

    • Ask a doctor if symptoms persist for more than 7 days or clear up and occur again within a few days
    • Rash,itching,execessive skin irritation develop
    • condition worsen or dose not improve after regular use
  • Inactives

    Rosin,Rinus(Ricinus communis),zinc oxide,Clematis chinensis root,Bee'wax,Myrrh(calcined),Mastic(calcined),Cochinchina momordica seed, Methyl salicylate,Indigo carmine(F,D&C# Blue),F,D&C #Yellow and Q.S with sesame oil to 1g

  • Storage and handling section

    •  Store in cool dry place from directly sunlight
    •  Re-seal package arter open
  • PRINCIPAL DISPLAY PANEL

    Image of DoctorRelief LabelImage of DoctorRelief Label

  • INGREDIENTS AND APPEARANCE
    DOCTORRELIEF 
    menthol patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57842-7734
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ROSIN (UNII: 88S87KL877)  
    RICINUS COMMUNIS WHOLE (UNII: Q94QWM85RF)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    CLEMATIS CHINENSIS ROOT (UNII: 8Z18N528CU)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MYRRH (UNII: JC71GJ1F3L)  
    PISTACIA LENTISCUS RESIN (UNII: 7446H202QW)  
    MOMORDICA COCHINCHINENSIS SEED (UNII: 2T87O1UPVD)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    INDIGOTINDISULFONATE SODIUM (UNII: D3741U8K7L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SESAME OIL (UNII: QX10HYY4QV)  
    QS-21 (UNII: 61H83WZX3U)  
    Product Characteristics
    Coloryellow (FD&C YELLOW NO. 5) , blue (FD&C BLUE NO. 2) , red (FD&C RED NO. 40) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57842-7734-110 in 1 CARTON; Type 0: Not a Combination Product02/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/03/2018
    Labeler - Biotanico Inc. (658835665)
    Registrant - Biotanico Inc. (658835665)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biotanico Inc.658835665manufacture(57842-7734)
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