Your browser does not support JavaScript! CAPZASIN HP ARTHRITIS PAIN RELIEF (CAPSAICIN) CREAM [CHATTEM, INC.]
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CAPZASIN HP ARTHRITIS PAIN RELIEF (capsaicin) cream
[Chattem, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Sections

Capzasin HP Arthritis Pain Relief

Active Ingredient

Capsaicin 0.1%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

For external use only

When using this product

  • use only as directed
  • do not bandage tightly or use with a heating pad
  • avoid contact with eyes and mucous membranes
  • do not apply to wounds, damaged, broken or irritated skin
  • a transient burning sensation may occur upon application but generally disappears in several days
  • if severe burning sensation occurs, discontinue use immediately and read important information printed inside carton
  • do not expose the area treated with product to heat or direct sunlight

Stop use and ask a doctor if

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children over 18 years:

  • apply to affected area
  • massage into painful area until thoroughly absorbed
  • repeat as necessary, but no more than 3 to 4 times daily
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

children 18 years or younger: ask a doctor

Inactive Ingredients

benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-40 stearate, petrolatum, sorbitol, water (238-10)

READ INFORMATION PRINTED INSIDE CARTON BEFORE USING.

KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION.             Recyclable Carton

Dist. by Chattem, Inc., P.O. Box 2219
Chattanooga, TN 37409-0219 U.S.A.
© 2009 www.chattem.com

Principal Display Panel

Deep Penetrating       Odor Free      
HIGH POTENCY
CAPZASIN HP®
ARTHRITIS PAIN RELIEF

CAPSA
ICIN 0.1% TOPICAL             ANALGESIC CREME              Net wt 1.5 oz (42.5 g)

Principal Display Panel - Net wt 1.5 oz (42.5 g)

CAPZASIN HP ARTHRITIS PAIN RELIEF 
capsaicin cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:41167-7514
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.001 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
PETROLATUM 
SORBITOL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:41167-7514-21 in 1 CARTON
142.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/01/1998
Labeler - Chattem, Inc. (003336013)
Establishment
NameAddressID/FEIBusiness Operations
Chattem Plant 1003336013ANALYSIS, LABEL, MANUFACTURE, PACK, RECOVERY, RELABEL, REPACK

Revised: 1/2010
 
Chattem, Inc.

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