Capsaicin 0.025% Cream
FDA Label NDC 73492-801

5 label sections · Submitted to the FDA by Alaina Healthcare Private Limited · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alaina Healthcare Private Limited for the product Capsaicin 0.025% (NDC 73492-801). 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 drug facts, uses, warnings, directions, principle display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredient                                                             Purpose

Capsaicin 0.025%....................................................External Analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to:

  • ​​​​​​​simple backache
  • arthritis
  • strains
  • sprains

Warnings

For external use only

​​​​​​​Read all warnings and directions before use. TEST FIRST ON SMALL AREA OF SKIN.

Directions

Adults and children 18 years of age and older:

  • use only as directed
  • apply a thin film of cream to affected area and gently rub in until fully absorbed
  • repeat as needed, but not more than 3 to 4 times daily
  • unless treating hands, wash hands thoroughly with soap and water immediately after application

    • Children under 18 years:ask a doctor

Principle Display Panel

CAPSAICIN 0.025% CREAM
EXTERNAL ANALGESIC
PENETRATING PAIN RELIEF
ARTHRITIS PAIN RELIEF
​​​​​​​Net Wt. 2.1 oz (60 g)

"image Description" (Capsaicin Cream 60g Tube Label)

"image Description" (Capsaicin Cream 60g Tube Label)

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