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Trixaicin

Qualitest Pharmaceuticals

Trixaicin Topical Analgesic Cream


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Capsicum oleoresin (containing capsaicin 0.025%)

Topical analgesic

  • 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

For external use only

  • 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.
  • 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.

  • 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
  • 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.

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

Trixaicin

Trixaicin

Capsicum oleoresin CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0603-0648
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CAPSICUM OLEORESIN 0.25 mg

Inactive Ingredients

Ingredient Name Strength
BENZYL ALCOHOL
CETYL ALCOHOL
DIGLYCOL STEARATE
GLYCERYL MONOSTEARATE
ISOPROPYL MYRISTATE
POLYOXYL 40 STEARATE
water
sorbitol
petrolatum

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 60 in 1 TUBE
2 NDC:0603-0648-88 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2001-09-01


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Be sure to consult your doctor before taking any medication!
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