Capsaicin Cream
FDA Label NDC 79643-011

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmacure Llc for the product Capsaicin (NDC 79643-011). 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, directions, other information, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                                     Purpose

Capsaicin 0.035%                                      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

• Conditions worsens or does not improve after regular use.
• Severe burning persists o blistering occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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 room temperature 15°-30°C (59°-86°F).
  • Protect product from excessive moisture.

Inactive Ingredients

Aqua (deionized water), arnica montana (arnica) extract, boswellia serrata extract, cetearyl olivate, cetyl alcohol, dimethyl sulfone (MSM), ethylhexylglycerin, glycerin, glyceryl stearate, hemp, sodium laurylglucosides hydroxypropylsulfonate, PEG-100 stearate, phenoxyethanol, polysorbate-20, resveratrol, sodium laurylglucosides hydroxypropylsulfonate, sorbitan olivate, stearic acid

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