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  5. Label Information: Capsaicin

FDA Label for Capsaicin

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PRINCIPAL DISPLAY PANEL – 120 GRAM TUBE
    13. PRINCIPAL DISPLAY PANEL – 50 GRAM TUBE

Capsaicin Product Label

The following document was submitted to the FDA by the labeler of this product Alexso, 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 0.025%


Purpose



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



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

Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away.


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 20-25oC (68-77oF); excursion permitted to 15-30oC (59-86oF). See USP Controlled Room Temperature.

Inactive Ingredients



Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsufonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine.


Principal Display Panel – 120 Gram Tube



NDC: 50488-1025-1
Capsaicin 0.025% Cream
120 grams

Manufactured for: Alexso, Inc.
2317 Cotner Avenue Los Angeles, CA 90064
Tel: 888.495.6078

Label


Principal Display Panel – 50 Gram Tube



Capsaicin 0.025% Cream
50 grams     NDC: 50488-1025-5

Manufactured for: Alexso, Inc.
2317 Cotner Avenue Los Angeles, CA 90064
Tel: 888.495.6078

Label


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