Zostrix Original Strength
FDA Label NDC 61787-442

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Akorn Consumer Health for the product Zostrix Original Strength (NDC 61787-442). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, uses, warnings, when using this product, stop use and ask a doctor if, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Capsaicin 0.025%

Purpose

Topical Analgesic

Keep Out Of Reach Of Children

If swallowed, get medical help or contact a PoisonControlCenter immediately.

Uses

  • for the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains

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.
  • avoid contact with eyes. 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 if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a doctor
  • blistering occurs
  • difficulty breathing or swallowing occurs
  • severe burning persists

Directions

  • for persons under 18 years of age, ask a doctor before using
  • apply a thin film of cream 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
  • see package insert for more information

Other Information

Store at 15°-30°C (59°-86°F)

Inactive Ingredients

benzyl alcohol, cetyl alcohol, glyceryl stearate, isopropyl myristate, PEG-100 stearate, purified water, sorbitol solution & white petrolatum.

Questions Or Comments?

Call: 1-866-263-9003, Mon-Thurs 9:00 am - 5:00 pm EST, Fri 9:00 am - 2:30 pm EST. Serious side effects associated with use of this product may be reported to this number.

* Please review the disclaimer below.