Label: ARTH RX TOPICAL ANALGESIC- methyl nicotinate, capsaicin lotion

  • 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 February 17, 2017

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

  • ACTIVE INGREDIENT

    Active Ingredients                  Purpose    
    Methyl nicotinate 0.5%          External Analgesic
    Capsaicin 0.025 %                External Analgesic

  • PURPOSE

    Uses: Temporarily relieves minor aches and pains of muscles and joints due to:

    - Arthritis - Strains - Sprains

  • WARNINGS

    WARNINGS

    FOR EXTERNAL USE ONLY

  • INDICATIONS & USAGE

    When Using This Product

    - Avoid contact with eyes
    - Do not apply to wounds or damaged skin
    - Do not bandage tightly

  • STOP USE

    Stop use and ask doctor if

    -  Condition worsens
    - Excessive irritation of the skin develops
    - Pain persists for more than 7 days
    - Symptoms clear up and occur again within a few days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed get medical help or contact a poison control center immediately.

  • DOSAGE & ADMINISTRATION

    Directions
    - Adults apply to affected area no more than 3-4 times daily
    - Children under 18 consult a physician
    - Apply to small area of the skin as test for sensitivity at least 60 minutes prior to applying to wide area.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Isopropanol, water, extracts of arnica and rue, polyacrylamide, C 13-14 isoparaffin. tween 80, laureth-7, boswellia, extract of chamomile, aloe, fragrance.

  • QUESTIONS

    Questions or comments

    Toll free 1-800-729-8446

  • DESCRIPTION

    Products containing capsaicin may cause a burning, stinging or tingling sensation where applied. This is a natural reaction and varies with each individual usually decreasing or disappearing after continued use. Please read package insert prior to use. ..........  may be removed from the test area by wiping or olive oil.

    Distributed by:
    HCD sales, Inc,
    Tampa, FL 33549
    www.hcdsales.com

  • PRINCIPAL DISPLAY PANEL

    arth.Rx  TOPICAL ANALGESIC  ARTHRITIS PAIN RELIEF  PENETRATING PAIN RELIEF, DOUBLE ACTION FORMULA WITH DOCTOR RECOMMENDED CAPSAICIN NEW WT 3 OZ (85 g)

  • PRINCIPAL DISPLAY PANEL

    Arth RX Topical Analgesic

  • INGREDIENTS AND APPEARANCE
    ARTH RX TOPICAL ANALGESIC 
    methyl nicotinate, capsaicin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76069-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL NICOTINATE (UNII: 7B1AVU9DJN) (NIACIN - UNII:2679MF687A) METHYL NICOTINATE0.5 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    WATER (UNII: 059QF0KO0R)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    LAURETH-7 (UNII: Z95S6G8201)  
    ALOE (UNII: V5VD430YW9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76069-100-0385 g in 1 BOTTLE; Type 0: Not a Combination Product02/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/12/2011
    Labeler - HCD Sales (137317314)