FDA Label for Scartrate Cream
View Indications, Usage & Precautions
Scartrate Cream Product Label
The following document was submitted to the FDA by the labeler of this product Puretek Corporation. 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.
Description:
Scartrate™ Cream contains 50 mg of Dimethicone and 22.5 mg of Alantoin per gram in a vehicle consisting of Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf (Aloe Vera) Juice, Aqua (Purified Water), Butylene Glycol, Carthamus Tinctorius (Safflower) Oil, Cetyl Alcohol, Dimethicone Crosspolymer, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (proprietary blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, sh-Polypeptide-121, Sodium Hydroxide, Stearic Acid, and Fragrance.
Indications And Usage:
Scartrate™ Cream is indicated for temporary protection and relief of chapped or cracked skin, it also effectively reduces the overall appearance of scars.
Dosage And Administration:
After cleansing, apply Scartrate™ Cream evenly to the affected area until it blends into the skin. Do not rinse off. Recommended for use in the morning (AM) and evening (PM). Reapply as needed to maintain skin protection and moisture.
Contraindications:
Do not use on deep or puncture wounds, animal bites, or serious burns.
Warnings And Precautions:
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
For external use only. Avoid contact with eyes. If the condition worsens, stop use and consult a licensed healthcare practitioner.
Adverse Reactions:
No adverse reactions have been reported under normal conditions of use. If you experience any unusual reactions, discontinue use and consult your licensed healthcare practitioner.
Use In Specific Populations:
Not specifically tested for use in pregnant or nursing women, children, or the elderly. Use caution and consult a licensed healthcare practitioner if you belong to one of these populations.
How Supplied:
Scartrate™ Cream is supplied in a 3 oz (85 g) tube (NDC 59088-326-07) with CRC Cap.
Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Keep container tightly closed.
Use under the direction of a licensed healthcare practitioner. Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873.
Package Label.Principal Display Panel
Manufactured by:
PureTek Corporation
Panorama City, CA 91402
For questions or information
call toll-free:
877-921-7873
* Please review the disclaimer below.
