Trixaicin HP

Dosage form: cream
Ingredients: CAPSICUM OLEORESIN 0.75mg in 1g
Labeler: Qualitest Pharmaceuticals
NDC Code: 0603-0649

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 HP

Active ingredient (in each gram)

Capsicum oleoresin (containing capsaicin 0.075%)

Purpose

Topical analgesic

Uses
  • for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains
  • for use in treating neuralgias, consult a physician

Warnings

For external use only

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

When using this product
  • you may experience a burning sensation which is normal and related to the way the product works. With regular use, this sensation generally disappears within several days.
  • do not get it on mucous membranes, into eyes, or on contact lenses. If this occurs, rinse the affected area thoroughly with water.
  • do not apply immediately before or after activities such as bathing, swimming, sun bathing, or strenuous exercise
  • do not apply heat to the treated areas immediately before or after use
  • do not tightly wrap or bandage the treated area
  • avoid inhaling airborne material from dried residue. This can result in coughing, sneezing, tearing, throat or respiratory irritation.

Stop use and ask a doctor if
  • condition worsens or does not improve after regular use
  • blistering occurs
  • difficulty breathing or swallowing occurs
  • severe burning persists

Keep out of reach of children.

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

Directions
  • for persons under 18 years of age, ask a doctor before using
  • apply a thin film of cream to the affected area and gently rub in until fully absorbed
  • for optimum relief, apply 3 to 4 times daily
  • best results typically occur after 2 to 4 weeks of continuous use
  • unless treating hands, wash hands thoroughly with soap and water immediately after use
  • if applying cream to hands, wait 30 minutes before washing hands

Other information
  • store at room temperature
  • Lot No. and Exp. Date: see crimp of tube or see box
  • to open: Unscrew cap. Use pointed end on cap to puncture seal.

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
8277586  0649

PRINCIPAL DISPLAY PANEL
TRIXAICIN HP 
capsicum oleoresin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0603-0649
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSICUM OLEORESIN (CAPSICUM) CAPSICUM OLEORESIN0.75 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CETYL ALCOHOL 
DIGLYCOL STEARATE 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
POLYOXYL 40 STEARATE 
WATER 
SORBITOL 
PETROLATUM 
Product Characteristics
ColorWHITE (white to off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0603-0649-881 TUBE (1 TUBE) in 1 CARTON
160 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34812/01/1995
Labeler - Qualitest Pharmaceuticals (011103059)
Establishment
NameAddressID/FEIOperations
Vintage Pharmaceuticals-Huntsville825839835MANUFACTURE

Revised: 12/2010
 
Qualitest Pharmaceuticals

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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