Capsaicin Cream
FDA Label NDC 50488-1025

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alexso, Inc for the product Capsaicin (NDC 50488-1025). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., 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

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.

Do Not Use

  • on wounds or damaged skin
  • if you are allergic to capsicum 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

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

Other Information

  • Store at 20-25oC (68-77oF); excursion permitted to 15-30oC (59-86oF). See USP Controlled Room Temperature.

Inactive Ingredients

Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.

Principal Display Panel – 120 Gram Tube

NDC: 50488-1025-1
Capsaicin 0.025% Cream
120 grams

Manufactured for: Alexso, Inc.
2317 Cotner Avenue Los Angeles, CA 90064
Tel: 888.495.6078

Label

Principal Display Panel – 50 Gram Tube

Capsaicin 0.025% Cream
50 grams     NDC: 50488-1025-5

Manufactured for: Alexso, Inc.
2317 Cotner Avenue Los Angeles, CA 90064
Tel: 888.495.6078

Label

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