CAPZASIN HP ARTHRITIS PAIN RELIEF- capsaicin cream

Capzasin HP Arthritis Pain Relief by

Drug Labeling and Warnings

Capzasin HP Arthritis Pain Relief by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., CHATTEM, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• read inside of carton before using
  
• use only as directed. Read and follow all directions and warnings on this carton/label. 
  
• avoid contact with the eyes and mucous membranes
  
• rare cases of serious burns have been reported with products of this type
  
• do not bandage tightly or apply local heat (such as heating pads) or a medicated patch to the area of use
  
• do not apply to wounds or damaged, broken or irritated skin
  
• do not use at the same time as other topical analgesics
  
• a transient burning sensation may occur upon application but generally disappears in several days
  
• if severe burning occurs, discontinue use immediately and read inside carton for important information
  
• do not expose the area treated with product to heat or direct sunlight
  
• avoid applying into skin folds

Stop use and ask a doctor if

• condition worsens
  
• redness is present
  
• irritation develops
  
• symptoms persist for more than 7 days or clear up and occur again within a few days
  
• you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

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

INGREDIENTS AND APPEARANCE

CAPZASIN HP ARTHRITIS PAIN RELIEF 
capsaicin cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-7514
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.001 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PETROLATUM (UNII: 4T6H12BN9U)
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-7514-2	1 in 1 CARTON	12/01/1998
1		42.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	12/01/1998

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 1		003336013	ANALYSIS(41167-7514) , LABEL(41167-7514) , MANUFACTURE(41167-7514) , PACK(41167-7514)