Capsaicin Cream 0.075% Cream
FDA Label NDC 73492-271

Full FDA labeling including 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 Cream 0.075% (NDC 73492-271). 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 factsactive ingredient                                                       purpose, uses, warnings, other information, inactive ingredients, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Factsactive Ingredient                                                       Purpose

Capsaicin 0.075%.............................................Topical 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.

Do not use

  • on wounds or damaged skin
  • if you are allergic to capsaicum or chili peppers

    • When using this product

    • you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
    • avoid contact with the eyes, lips, nose and mucous membranes
    • do not tightly wrap or bandage the treated area
    • do not apply heat to the treated area immediately before or after use

      • Stop use and ask a doctor if

      • condition worsens or does not improve after regular use
      • severe burning persists or blistering occurs

Other Information

Store at 20° C-25° C (68° F-77° F); excursions permitted to 15° C-30° C (59° F-86° F). See USP Controlled Room Temperature.

Inactive Ingredients

aloe barbadensis leaf juice, cetyl alcohol, glyceryl stearate, mineral oil, PEG-100 stearate, peppermint oil, petrolatum, phenoxyethanol, propylene glycol, stearyl alcohol, water, xanthan gum

Principal Display Panel

Capsaicin Cream 0.075% - NDC 73492-271-60 - 2.11 OZ (60g) Tube Label

Image Description (Capsaicin Cream 60g Tube Label)

Image Description (Capsaicin Cream 60g Tube Label)

Capsaicin Cream 0.075% - NDC 73492-271-60 - 2.11 OZ (60g) Carton Label

Image Description (Capsaicin Cream 60g Carton Label)

Image Description (Capsaicin Cream 60g Carton Label)

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