CAPSAICIN- capsaicin 0.15% liquid

Capsaicin by

Drug Labeling and Warnings

Capsaicin by is a Otc medication manufactured, distributed, or labeled by Top Care, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                      Purpose
Capsaicin 0.15%......................................................................Topical analgesic

PURPOSE

INDICATIONS & USAGE

Uses
Temporarily relieves minor aches and pains of muscles and joints associated with: arthritis simple backache strains sprains bruises

WARNINGS

Warnings
For external use only
When using this product Use only as directed Do not bandage tightly
Do not 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
package insert for important information
Do not expose the area treated with product to heat or direct sunlight
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
Flammable Keep away from fire or flame

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

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
IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER
Children 18 years or younger: ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

Carbomer, Glycerin, Propylene Glycol, SD
Alcohol 40-2 (35%), Triethanolamine, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CAPSAICIN 
capsaicin 0.15% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-729
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Capsaicin (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	Capsaicin	0.15 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
Glycerin (UNII: PDC6A3C0OX)
Propylene Glycol (UNII: 6DC9Q167V3)
Alcohol (UNII: 3K9958V90M)
TROLAMINE (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-729-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	10/20/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/20/2011

Labeler - Top Care (006935977)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(36800-729) , label(36800-729)