CAPZASIN QUICK RELIEF- capsaicin and menthol gel

Capzasin Quick Relief by

Drug Labeling and Warnings

Capzasin Quick 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 Quick Relief Gel

Active Ingredient

Capsaicin 0.025%

Purpose

Topical analgesic

Active Ingredient

Menthol 10%

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

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:

• squeeze desired amount of Capzasin Quick Relief Gel onto affected area
  
• using the sponge-top applicator, massage dispensed gel 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

acrylates/C10-30 alkyl acrylate crosspolymer, allantoin, aloe barbadensis leaf juice, DMDM hydantoin, fragrance, glycerin, methylparaben, phenoxyethanol, propylene glycol, propylparaben, SD alcohol 40-2 (15%), steareth-2, steareth-21, triethanolamine, water (245-285)


KEEP CARTON AS IT CONTAINS IMPORTANT INFORMATION.

Distributed by: Chattem, Inc.
P.O. Box 2219
Chattanooga, TN 37409-0219
0049618-03       U.S.A. ©2010 www.chattem.com        Recyclable Carton

Principal Display Panel

ARTHRITIS PAIN RELIEF
CAPZASIN TM
QUICK RELIEF GEL

• #1 Pharmacist
  Recommended*
  
• Two Strong
  Pain Relievers
  
• Starts to Work
  on Contact

NO-MESS
Sponge Applicator
PURIFIED
P
CAPSAICIN®
Topical Analgesic Gel
*SOURCE: 2009 Pharmacy Today Survey
Net wt 1.5 oz (42.5 g)

INGREDIENTS AND APPEARANCE

CAPZASIN QUICK RELIEF 
capsaicin and menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41167-7516
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.00025 g  in 1 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.1 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41167-7516-0	1 in 1 CARTON	12/01/2008
1		42.5 g in 1 TUBE, 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	12/01/2008

Labeler - Chattem, Inc. (003336013)

Establishment
Name	Address	ID/FEI	Business Operations
Chattem Plant 1		003336013	ANALYSIS(41167-7516) , LABEL(41167-7516) , MANUFACTURE(41167-7516) , PACK(41167-7516)