FDA Label for Dermisa Skin Fade Vitamin C Infused
View Indications, Usage & Precautions
Dermisa Skin Fade Vitamin C Infused Product Label
The following document was submitted to the FDA by the labeler of this product Montani Cosmetics Inc. 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.
Active Ingredient
Hydroquinone USP 2%
Octyl Dimethyl Paba 0.60%
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
* Please review the disclaimer below.