Active Ingredient
Hydroquinone USP 2%
Octyl Dimethyl Paba 0.60%
Dermisa
FDA Label NDC 68343-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Montani Cosmetics Inc for the product Dermisa (NDC 68343-005). 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, do not use, when using this product, 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
Skin Lightener
Uses
• For the gradual fading of dark (brownish) skin discolorations such as freckles, age and liver spots or uneven pigment that may occur due to sun overexposure, pregnancy or from the use of oral contraceptives.
Warnings
For external use only
Do Not Use
• On children under 12 years of age unless directed by a doctor • This product is not for use in the prevention of sunburn • On inflamed or broken skin
When Using This Product
• Avoid contact with the eyes • Some users of this product may experience a mild skin irritation, if skin irritation becomes severe stop use and consult a doctor
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away
Directions
• Adults Apply a small amount as a thin layer to the affected areas twice daily or as directed by a doctor. If no improvement is seen after 3 months of treatment, use of this product should be discontinued.Lightening effect of this product may not be noticeable when used on very dark skin. • Children under 12 years of age Do not use unless directed by a doctor
• Sun exposure should be limited by using a sunscreen agent, or protective clothing to prevent bleached skin after treatment completed to prevent darkening from recurring
Other Information
• Store at room temperature • Tamper-evident tube • Contact us at contractar en [email protected]
Inactive Ingredients
Water (Aqua), Glycerin, Paraffinum Liquidum (Mineral Oil), Stearyl Alcohol, Petrolatum, Cetearyl Alcohol, Steareth-10, Propylene Glycol, Steareth-2, Sodium Sulfite, Citric Acid, Sodium Metabisulphate, Diazolidinyl Urea, Dicetyl Phosphate, Ceteth-10 Phosphate, Fragrance (Parfum), Methylparaben, Propylparaben, Ethylhexyl Methoxyinnamate, Limonene, Hydroxycitronellol, Ascorbic Acid (Vitamin C)
Package Label
Carton Label (Drmsaskncrm)
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