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  5. Label Information: Capsaicin Cream 0.1%

FDA Label for Capsaicin Cream 0.1%

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DIRECTIONS
    6. OTHER INFORMATION
    7. INACTIVE INGREDIENTS
    8. PRODUCT LABEL

Capsaicin Cream 0.1% Product Label

The following document was submitted to the FDA by the labeler of this product Pharmaceutica North America, 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.

Active Ingredient



Capsaicin 0.1%


Purpose



Topical Analgesic


Uses



For the temporary relief of minor aches and pains of muscles and joints associated with:
• Arthritis
• Simple Backache
• Strains
• Sprains
• Bruises


Warnings



For external use only: TEST FIRST ON SMALL AREA OF SKIN.
When using this product:

Due not use

  • Do not apply to wounds, damaged, broken or irritated sin
  • if you are allergic to capssicum or chili peppers

    • When using this product

    • use only as directed
    • Do not apply to wounds, damaged, broken or irritated sin
    • Do not use if you are allergic to capssicum or chili peppers
    • Avoid contact with the eyes or mucous membranes
    • A slight burning sensation may occur upon application, but generally disappears after several days of use
    • If severe burning occurs, discontinue use
    • Do not expose the treated area to heat or direct sunlight
    • Do not bandage
    • Do not use with heating pad

      • Stop Use and Ask Doctor if:
      • Condition worsens
      • Symptoms persist for more than 7 days or clear up and occur again within a few days
      • Redness is present
      • irritation develops
      Keep Out of the Reach of Children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.


Directions



• do not take more than directed (see overdose warning)
adults and children over 18 years and over:

  • apply to affected area 
  • massage into the painful area until throughly absorbed 
  • repeat as necessary but not more than 3 to 4 times daily
  • WASH HANDS WITH SOAP AND WATER AFTER APPLYING

    • children under 18 years and younger:ask a doctor


Other Information



• store at room temperature 15° - 30°C (59 - 86°F)


Inactive Ingredients



Aloe barbadensis leaf juice, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Polyoxyethylene lauryl ether, Purified Water, stearic acid.


Product Label



image description - image 74 1

image description - image 74 1


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