Capsaicin Cream
FDA Label NDC 50268-197

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Avpak for the product Capsaicin (NDC 50268-197). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient: Capsaicin 0.1%

Otc - Purpose

Purpose: Topical Analgesic

Indications & Usage

Uses: Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Warnings

Warnings: For external use only.

Do not use:

  • on wounds or damaged skin
  • if you are allergic to capsicum or chili peppers
  • with heating pad

    • When using this produce:

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions – Adults and children 18 years of age and older

  • apply a thin film of cream to affected area and gently rub in until fully absorbed
  • unless treating hands, wash hands thoroughly with soap and water immediately after application
  • for best results, apply 3 to 4 times daily


    • Children under 18 years: ask a doctor.

Storage And Handling

Other Information:store at room temperature 15° - 30°C (59° - 86°F)

Inactive Ingredient

Inactive Ingredients: Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum

Other

Questions? Comments?

1-855-361-3993

Manufactured for:

AvKARE, Pulaski, TN 38478

www.avkare.com

AV 06/22

Packaging

56 (197 56)

56 (197 56)

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