CAPSAICIN- capsaicin 0.15% liquid 
Top Care

Disclaimer: 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.

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Drug Facts

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

Uses
Temporarily relieves minor aches and pains 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
• 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. 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
• 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.

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CAPSAICIN 
capsaicin 0.15% liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-729
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Capsaicin (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) Capsaicin0.15 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-729-0130 mL in 1 TUBE; Type 0: Not a Combination Product10/20/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34810/20/2011
Labeler - Top Care (006935977)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(36800-729) , label(36800-729)

Revised: 7/2018
Document Id: 92ed34a7-11d0-48ea-8804-40e265ec07af
Set id: 697d654a-5079-43d3-8f88-99fe3b40ed54
Version: 1
Effective Time: 20180718
 
Top Care