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  5. Label Information: Dermisa Skin Fade

FDA Label for Dermisa Skin Fade

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USE
    4. WARNINGS
    5. KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. INACTIVE INGREDIENTS
    8. PACKAGE LABEL

Dermisa Skin Fade 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
Sunscreen


Use




  • Lightens dark discolorations in the skin such as age spots, liver spots, freckles, minor scars and pigment in skin that may occur during pregnancy or from the use of oral contraceptives.
  • Contains a sunscreen to help prevent darkening from reoccurring.

Warnings



  • For external use only. Avoid contact with eyes. Some users of  this product may experience a mild skin irritation. If irritation becomes severe, stop use and consult a doctor. Do not use on children under 12 years of age unless directed by a doctor. Sun exposure should be limited by using a sunscreen agent, a sunblocking agent or protective clothing to cover bleached skin after treatment to prevent darkening from recurring. This product is not for the use in the prevention of sunburn

Keep Out Of Reach Of Children



  • If swallowed, get medical help or contact a Poison Control Center immediately.

Directions



  • 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.
  • Indications: For the gradual fading of dark age spots, liver spots, freckles and melasma (a condition caused during pregnancy or by the use of oral contraceptives)


Inactive Ingredients



Water, Glyceryl Monostearate, Mineral Oil, Propylene Glycol, Cetyl Alcohol, Dimethicone, Sodium Lauryl Sulphate, Disodium EDTA, Ascorbic Acid (Vitamin C), Sodium Metabisulphite, Propylparaben, Fragrance, Allantoin


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