CAPZASIN NO MESS APPLICATOR- capsaicin liquid

Capzasin No Mess Applicator by

Drug Labeling and Warnings

Capzasin No Mess Applicator by is a Otc medication manufactured, distributed, or labeled by Chattem, Inc., Chattem Plant 1. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Capzasin No Mess Applicator

Active Ingredient

Capsaicin 0.15%

Purpose

Topical analgesic

Uses

temporarily relieves minor pain associated with:

• arthritis
  
• simple backache
  
• muscle strains
  
• sprains
  
• bruises
  
• cramps

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

Flammable

keep away from fire or flame

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
  
• place applicator on skin, press firmly and hold to activate the dispensing of liquid
  
• massage into painful area until thoroughly absorbed
  
• repeat as necessary, but no more than 3 to 4 times daily
  
• IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER

children 18 years or younger: ask a doctor

Inactive Ingredients

carbomer, glycerin, propylene glycol, SD alcohol 40-2 (35%), triethanolamine, water (245-130)


KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION.

Close cap tightly after use.                         0042763-04

Dist. by Chattem, Inc., P.O. Box 2219

Chattanooga, TN 37409-0219

U.S.A. © 2009 www.chattem.com                   Recyclable Carton

Principal Display Panel

ARTHRITIS PAIN RELIEF
CAPSAICIN 0.15%

CAPZASIN TM
NO-MESS APPLICATOR

• Doctor
  Recommended*
  
• High Potency
  
• Odor Free

Topical

Analgesic

Liquid
1 fl oz (29.5 mL)

*Refers to the ingredient capsaicin

INGREDIENTS AND APPEARANCE

CAPZASIN NO MESS APPLICATOR 
capsaicin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-7518
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.0015 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-7518-1	1 in 1 CARTON	12/01/2006
1		29.5 mL in 1 BOTTLE, WITH APPLICATOR; 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	12/01/2006

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 1		003336013	ANALYSIS(41167-7518) , LABEL(41167-7518) , MANUFACTURE(41167-7518) , PACK(41167-7518)