TRIXAICIN- capsicum oleoresin cream 
Qualitest Pharmaceuticals

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.

----------

Trixaicin Topical Analgesic Cream

Active ingredient (in each gram)

Capsicum oleoresin (containing capsaicin 0.025%)

Purpose

Topical analgesic

Uses

Warnings

For external use only

Do not apply to wounds or to damaged or irritated skin.

When using this product

Stop use and ask a doctor if

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

You may report serious side effects to: 130 Vintage Drive, Huntsville, AL 35811.

Inactive ingredients

benzyl alcohol, cetyl alcohol, diglycol stearate, glyceryl monostearate, isopropyl myristate, PEG-40 stearate, purified water, sorbitol solution, white petrolatum

Made in the USA for
Qualitest Pharmaceuticals
Huntsville, AL 35811

Rev. 3/10 R3
8277581 0648

PRINCIPAL DISPLAY PANEL

This is an image of the carton for Trixaicin Topical Analgesic Cream.
TRIXAICIN 
capsicum oleoresin cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0603-0648
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSICUM OLEORESIN (CAPSICUM) CAPSICUM OLEORESIN0.25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETYL ALCOHOL 
DIGLYCOL STEARATE 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
POLYOXYL 40 STEARATE 
WATER 
SORBITOL 
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0603-0648-881 in 1 CARTON
160 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34809/01/2001
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIBusiness Operations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE

Revised: 7/2010
Document Id: 6359d4bf-9438-4cc5-8d82-123fc13ccac8
Set id: af1128e4-58e9-4c45-8320-bbc5b8ce0147
Version: 2
Effective Time: 20100715
 
Qualitest Pharmaceuticals