Capsaicin Cream
FDA Label NDC 0536-2525

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories for the product Capsaicin (NDC 0536-2525). 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 other, active ingredient, purpose, uses, otc - do not use, when using this product, stop use and ask a doctor if, otc - 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

Other

Drug Facts

Mfd for:
Rugby Laboratories, Inc.
Duluth, Georgia 30097

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

Otc - Do Not Use

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

Otc - Keep Out Of Reach Of Children

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)

Inactive Ingredients

acrylates/C10-30 alkyl acrylate crosspolymer, cetyl acetate, methylparaben, PPG-20 methyl glucose ether distearate, propylene glycol, propylparaben, stearate-100, stearic acid, stearyl alcohol, triethanolamine, water

Questions Or Comments?

Call 1-800-645-2158 9 am - 5 pm ET, Monday - Friday

Principal Display Panel - 60 G Tube Carton

NDC 0536-2525-25

Rugby®

SATISFACTION GUARANTEED
Rugby
OR YOUR MONEY BACK

Capsaicin Cream, 0.025%

External Analgesic
Penetrating Pain Relief

Net Wt 2.1 oz (60 g)

Principal Display Panel (60 g Tube Carton)

Principal Display Panel (60 g Tube Carton)

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