Active Ingredient
Menthol 2%
Capsaicin 0.05%
Diabecin Cs Cream
FDA Label NDC 59088-794
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Puretek Corporation for the product Diabecin Cs Cream (NDC 59088-794). 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, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Menthol -Topical Analgesic
Capsaicin- Topical Analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
Warnings
For external use only
• This is not a face cream. Do not apply to the face.
• Do not use at the same time with other topical analgesics.
• Do not use if allergic to chili peppers or if past allergic reaction to capsaicin.
• Do not apply to wounds or damaged 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 burn.
When Using This Product
• Avoid contact with the eyes.
Stop Use And Ask A Doctor If
• condition worsens • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
• Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.
• 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 in a cool well-ventilated area away from heat. Keep away from sparks or open flame. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Do not use if package is damaged.
Inactive Ingredients:
Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Beta-Sitosterol, Bisabolol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Calcium Pantothenate (Vitamin B5), Calendula Officinalis (Calendula) Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, DL-Alpha-Tocopheryl Acetate (Vitamin E), Escin, Ginkgo Biloba (Ginkgo) Leaf Extract, Glycerin, Glyceryl Stearate, Imidazolidinyl Urea, Isopropyl Myristate, Laureth-7, Lecithin, Maltodextrin, Myristyl Myristate, Niacinamide (Vitamin B3), Nylon-12, PEG-100 Stearate, Peucedanum Ostruthium (Masterwort) Leaf Extract, Phenoxyethanol, Polyacrylamide, Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Zingiber Officinale (Ginger) Root Extract.
Diabecin Cs™ Cream
Manufactured by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free:
877-921-7873
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