NDC 68343-001 Dermisa Skin Fade

NDC Product Code 68343-001

NDC 68343-001-01

Package Description: 1 TUBE in 1 BOX > 50 g in 1 TUBE (68343-001-50)

NDC 68343-001-02

Package Description: 1 TUBE in 1 BOX > 25 g in 1 TUBE (68343-001-25)

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Dermisa Skin Fade with NDC 68343-001 is a product labeled by Montani Cosmetics Inc. The generic name of Dermisa Skin Fade is . The product's dosage form is and is administered via form.

Labeler Name: Montani Cosmetics Inc

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SODIUM LAURYL SULFATE (UNII: 368GB5141J)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • ALLANTOIN (UNII: 344S277G0Z)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Montani Cosmetics Inc
Labeler Code: 68343
Start Marketing Date: 09-15-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dermisa Skin Fade Product Label Images

Dermisa Skin Fade Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling 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

* Please review the disclaimer below.