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ARTH RX TOPICAL ANALGESIC (methyl nicotinate, capsaicin) lotion
[HCD Sales]


NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKEDTED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.

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

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

- Arthritis - Strains - Sprains

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY

INDICATIONS AND USAGE

When Using This Product

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

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. If swallowed get medical help or contact a poison control center immediately.

DOSAGE AND 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 Ingredients

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

Questions or comments

Toll free 1-800-729-8446

DESCRIPTION SECTION

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 & APPEARANCE

ARTH RX TOPICAL ANALGESIC 
methyl nicotinate, capsaicin lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:76069-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
METHYL NICOTINATE (METHYL NICOTINATE) METHYL NICOTINATE0.5 g  in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN0.025 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ISOPROPYL ALCOHOL 
WATER 
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) 
C13-14 ISOPARAFFIN 
POLYSORBATE 80 
LAURETH-7 
ALOE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76069-100-0385 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34802/12/2011
Labeler - HCD Sales (137317314)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source Inc.969241041manufacture

Revised: 3/2011
 
HCD Sales