1. Home
  2. Labeler Index
  3. Violacare, Inc.
  4. 85231-202
  5. Label Information: Capsaicin 0.075% Cream

FDA Label for Capsaicin 0.075% Cream

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTSACTIVE INGREDIENT  PURPOSE
    2. USES
    3. WARNINGS
    4. OTHER INFORMATION
    5. INACTIVE INGREDIENTS
    6. PRINCIPAL DISPLAY PANEL

Capsaicin 0.075% Cream Product Label

The following document was submitted to the FDA by the labeler of this product Violacare, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Factsactive Ingredient  Purpose



Capsaicin 0.075%.............................................Topical 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 the skin.

Do not use

  • on wounds or damaged skin
  • if you are allergic to capsaicum 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 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 doctor if

      • condition worsens or does not improve after regular use
      • severe burning persists or blistering occurs

Other Information



Store at 20° C-25° C (68° F-77° F); excursions permitted to 15° C-30° C (59° F-86° F). See USP Controlled Room Temperature.


Inactive Ingredients



aloe barbadensis leaf juice, cetyl alcohol, glyceryl stearate, mineral oil, PEG-100 stearate, peppermint oil, petrolatum, phenoxyethanol, propylene glycol, stearyl alcohol, water, xanthan gum


Principal Display Panel



Capsaicin 0.075% Cream - NDC 85231-202-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g) Tube Label

image description - capsaicin cream 60g tube label

image description - capsaicin cream 60g tube label

Capsaicin 0.075% Cream - NDC 85231-202-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g) Carton Label

Manufactured For:

ViolaCare, Inc.

Parsippany, New Jersey, 07054


* Please review the disclaimer below.