Dermisa
FDA Label NDC 68343-001

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 68343-001). 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, use, warnings, keep out of reach of children, directions, inactive ingredients, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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