DERMISA SKIN FADE VITAMIN C INFUSED- hydroquinone cream

Dermisa by

Drug Labeling and Warnings

Dermisa by is a Otc medication manufactured, distributed, or labeled by Montani Cosmetics Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydroquinone USP 2%

Octyl Dimethyl Paba 0.60%

Purpose

Skin Lightener

Uses

Ÿ ŸFŸor 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 info@dermisa.com

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

INGREDIENTS AND APPEARANCE

DERMISA  SKIN FADE VITAMIN C INFUSED
hydroquinone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68343-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE)	HYDROQUINONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
SODIUM SULFITE (UNII: VTK01UQK3G)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
OCTINOXATE (UNII: 4Y5P7MUD51)
HYDROXYCITRONELLOL (UNII: R0B4U2I48W)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERIN (UNII: PDC6A3C0OX)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PETROLATUM (UNII: 4T6H12BN9U)
STEARETH-10 (UNII: FD0913P475)
STEARETH-2 (UNII: V56DFE46J5)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
METHYLPARABEN (UNII: A2I8C7HI9T)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68343-005-01	1 in 1 BOX	07/16/2018
1	NDC: 68343-005-50	50 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68343-005-02	1 in 1 BOX	07/16/2018
2	NDC: 68343-005-25	25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part358A	07/16/2018

Labeler - Montani Cosmetics Inc (124852331)