Capsaicin 0.035% Cream
FDA Label NDC 82461-417

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medcore Llc for the product Capsaicin 0.035% Cream (NDC 82461-417). 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 uses, warnings, do not use :, when using this product, stop use and ask a doctor if, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Directions

Adults and children 18 years 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 18years：ask a doctor

Other Information

excursions permitted to 15-30C(59-86F).
See USP Controlled Room Temperature.

Inactive Ingredients

Poly(acrylic acid) solution, Polysorbate 80, Glycerin, polyethylene glycol-400, Sodium polyacrylate, SORBITOL, Carboxymethyl Cellulose Sodium, aluminium magnesium silicate, PHENOXYETHANOL, EDTA Disodium salt, Lemon oil, Water, Peppermint oil

Principal Display Panel

NDC: 82461-417-10

Medcore LLC

Capsaicin 0.035% cream

100ml

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

Capsaicin (Capsaicin 01)

Capsaicin (Capsaicin 01)

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