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Name:Arth Rx Topical Analgesic
Manufacturer:Hcd Sales
Category:Over-the-counter (OTC) Marketed Drugs


Arth RX Topical Analgesic

ARTH RX TOPICAL ANALGESIC  - methyl nicotinate and capsaicin lotion 
HCD Sales

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.

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Arth RX Topical Analgesic

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

FOR EXTERNAL USE ONLY

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.

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

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

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

Arth RX Topical Analgesic


ARTH RX TOPICAL ANALGESIC 
methyl nicotinate, capsaicin lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:76069-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
METHYL NICOTINATE (METHYL NICOTINATE) METHYL NICOTINATE 0.5 g  in 100 g
CAPSAICIN (CAPSAICIN) CAPSAICIN 0.025 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL  
WATER  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)  
C13-14 ISOPARAFFIN  
POLYSORBATE 80  
LAURETH-7  
ALOE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76069-100-03 85 g in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part348 02/12/2011

Labeler - HCD Sales (137317314)
Establishment
Name Address ID/FEI Operations
Pure Source Inc. 969241041 manufacture

Revised: 03/2011 HCD Sales



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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