Label: DR TANS PAIN RELEIVING 3 DAY HERABL PATCH- peppermint 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 May 26, 2017

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  • Actives

    PEPPERMINT 0.3 % 

  • Inactives

    Angelica Dahurica, Angelica Pubescens Maxim. f. , Carthamus Tinctorius, Draconis Sanguis, Drynaria Rhizome, Ligusticum Wallichii, Notopterygium lncisum, Phellodendron Amurense, Radix Angelicae Formosanae, Radix Angelicae Pubescentis, Rhizoma Corydalis, hydrogel.

  • Purpose

    External Analgesic

  • Indication and Usage

    For adults and children 10 and older for the temporary relief of: • chronic arthritis • backache • joint and muscle pain and stiffness • old sports injuries.

  • Directions 

    Clean and dry the affected area. Peel film off of patch and apply the herbal-formula side onto the skin. Peel film off the larger dressing patch and apply over the herbal patch to secure it in place. Patch will continue to release herbal formula to the skin for 3 days if desired.

  • Warnings

    • For external use only. • Do not apply to open sores or wounds. • If skin irritation or a rash occurs, remove patch and consult physician. ·Avoid contact with eyes and mucous membranes. • If pregnant or breast feeding, consult a doctor before using.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children 

  • Product label 

    pain-relief

  • INGREDIENTS AND APPEARANCE
    DR TANS PAIN RELEIVING 3 DAY HERABL PATCH 
    peppermint patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71446-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL0.3 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ANGELICA PUBESCENS ROOT (UNII: 0MF1EI01KJ)  
    CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0)  
    DRAGON'S BLOOD (UNII: M3YJ2C28IC)  
    DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q)  
    LIGUSTICUM WALLICHII ROOT (UNII: R81AD159QS)  
    NOTOPTERYGIUM INCISUM ROOT (UNII: 5Z2WW4J6RI)  
    PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)  
    ANGELICA DAHURICA VAR. FORMOSANA ROOT (UNII: 924AE5NXTL)  
    DICENTRA CANADENSIS ROOT (UNII: Y5JS7YM46F)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CROSPOVIDONE, UNSPECIFIED (UNII: 2S7830E561)  
    POVIDONE K90 (UNII: RDH86HJV5Z)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71446-002-012 in 1 PACKAGE05/25/2017
    10.3 g in 1 PATCH; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/25/2017
    Labeler - Great Loong LLC (041552971)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tianjin Ruide Pharmaceutical Co., Ltd.547738337manufacture(71446-002)