Active Ingridient
Capsaicin 0.035%
Capsaicin 0.035% Cream
FDA Label NDC 59088-246
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretekcorp for the product Capsaicin 0.035% Cream (NDC 59088-246). 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 ingridient, purpose, uses, warnings, when using this product, otc - stop use, otc - ask doctor, 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
Purpose
Topical Analgesic
Uses
for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains.
Warnings
For external use only
• This is not a face cream. Do not apply to the face.
• Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.
• Do not apply to wounds or damaged , broken, sunburned, chapped or irritated skin.
• Do not bandage tightly.
• Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and burning sensation.
• Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.
When Using This Product
Do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.
Otc - Stop Use
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use and consult a doctor.
Otc - Ask Doctor
If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If
inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.
Directions
• Rotate pump’s spout counter-clockwise slightly to unlock; clockwise to lock.
• Before using on children under 18 years of age consult a physician.
• Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small area to test for sensitivity or skin reaction.
• Gently massage into the skin until fully absorbed.
• Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.
Other Information
Store at controlled room temperature 20° to 25°C (68° to 77°F). [See USP]. Protect from light and moisture and avoid excessive heat.
Inactive Ingredients
Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Bisabolol,
C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Calcium Pantothenate (Vitamin B5), Calendula Officinalis Flower
Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower
Extract, Dimethicone, DL-Alpha-Tocopheryl Acetate (Vitamin E), Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin,
Glyceryl Stearate, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Maltodextrin, Myristyl
Myristate, Niacinamide (Vitamin B3), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Pyridoxine HCl (Vitamin
B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate,
Zingiber Officinale (Ginger) Root Extract.
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