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.

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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 Type HUMAN OTC DRUG Item Code (Source) NDC:0603-0648
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAPSICUM OLEORESIN (UNII: UW86K581WY) (CAPSICUM - UNII:00UK7646FG) CAPSICUM OLEORESIN 0.25 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIGLYCOL STEARATE (UNII: 94YQ11Y95F)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0603-0648-88 1 in 1 CARTON
1 60 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part348 09/01/2001
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
Name Address ID/FEI Business Operations
Vintage Pharmaceuticals-Huntsville 825839835 MANUFACTURE

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