Active Ingredient
Capsaicin 0.1%
Capsaicin Cream
FDA Label NDC 81533-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Noble Otc Llc for the product Capsaicin Cream (NDC 81533-200). 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 active ingredient, purpose, warnings, stop use and ask doctor, keep out of the reach of children, uses, if pregnant or breast feeding, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical Analgesic
Warnings
For external use only: TEST FIRST ON SMALL AREA OF SKIN.
When using this product:
- Use only as directed
- Do not apply to wounds, damaged, broken or irritated skin
- Do not use if you are allergic to capsicum 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
- 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
- Do not use at the same time as other topical analgesics
Stop Use And Ask Doctor
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
- You experience signs of skin injury such as pain, swelling or blistering.
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with:
- Arthritis
- Simple Backache
- Strains
- Sprains
- Bruises
If Pregnant Or Breast Feeding
Ask a doctor before use
Directions
Adults and Children over 18 years:
- Apply to affected area
- Massage into the painful area until thoroughly absorbed
- Repeat as necessary but not more than 3 to 4 times daily
- WASH HANDS WITH SOAP AND WATER AFTER APPLYING
Children 18 years and younger:
Ask a doctor
Inactive Ingredients
Aloe barbadensis leaf juice, Cetostearyl alcohol, Ethylparaben, Glycerin, Glyceryl monostearate, Mineral Oil, Petrolatum, Purified Water, Polyoxyethylene Lauryl Ether, Stearic Acid
Other Information
Store at room temperature 15°-30°F (59°-86°F)
This product is not manufactured or distributed by Chattem, distributor of Capzaicin-HP arthritis pain relief.
Manufactured for
Noble OTC LLC
Perth Amboy, NJ 08861
www.nobleotc.com
This product is not manufactured or distributed by Chattem, a distributor of Capzaicin-HP Arthritis Pain Relief
Questions
Questions or Comments
Please call Toll Free 1-888-296-9067
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