Curefini Cream
FDA Label NDC 79974-203
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Miramar Cosmetics, Inc Dba Miramar Lab for the product Curefini (NDC 79974-203). 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 drug facts:, active ingredient:, purpose, uses:, warnings:, otc - keep out of reach of children, directions:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient:
Petrolatum.............30.00%
Purpose
Skin Protectant
Uses:
• For temporary protection of minor cuts, scrapes and burns.
• For temporary protection of cracked and chapped skin.
• Helps protect from the drying effects of wind and cold weather.
Warnings:
For external use only
• Avoid contact with eyes.
• If symptoms persist for more than seven days, discontinue use and consult physician.
Otc - Keep Out Of Reach Of Children
• Keep out of reach of children. If swallowed, consult physician.
• Do not use if tamper evident seal is broken.
Directions:
Apply daily over the affected area, with soft massages to ease absorption. Repeat application as many times as needed to keep skin permanently moisturized.
Other Information:
• Store at room temperature.
• Do not use if tamper evident seal is broken.
Inactive Ingredients:
Aqua (Deionized Water), Beeswax, Cetearyl Alcohol, Cetearyl Olivate, Cetearyl Glucoside, Chamomilla Recutitta (Chamomile) Extract, Chamomilla Recutitta (Chamomile) Oil, Cocamidopropyl Betaine, Ethylhexylglycerin, Gadi Lecur (Cod Liver) Oil, Helianthus Annuus (Sunflower) Seed Oil, Phenoxyethanol, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E).
Questions?
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Packaging
Cream203 (7997420301 06)
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