DERMISA SKIN FADE - hydroquinone and padimate o cream
Montani Cosmetics Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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

Carton Label

Package Label

DERMISA SKIN FADE
hydroquinone padimate o cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68343-001
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (HYDROQUINONE)	HYDROQUINONE	2 g in 100 g
PADIMATE O (PADIMATE O)	PADIMATE O	0.6 g in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER
MINERAL OIL
GLYCERYL MONOSTEARATE
PROPYLENE GLYCOL
CETYL ALCOHOL
DIMETHICONE
SODIUM LAURYL SULFATE
EDETATE DISODIUM
ASCORBIC ACID
SODIUM METABISULFITE
PROPYLPARABEN
ALLANTOIN

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Multilevel Packaging
1	NDC:68343-001-01	1 TUBE ( TUBE) in 1 BOX	contains a TUBE (68343-001-50)
1	NDC:68343-001-50	50 g in 1 TUBE	This package is contained within the BOX (68343-001-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	09/15/2011

Labeler - Montani Cosmetics Inc (124852331)

Establishment
Name	Address	ID/FEI	Operations
Cleanliness Ltd		232500475	manufacture

Revised: 08/2011 Montani Cosmetics Inc