DERMISA SKIN FADE VITAMIN C INFUSED- hydroquinone 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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Drug Facts

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

Carton Label

DERMISA  SKIN FADE VITAMIN C INFUSED
hydroquinone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68343-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68343-005-011 in 1 BOX07/16/2018
1NDC:68343-005-5050 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:68343-005-021 in 1 BOX07/16/2018
2NDC:68343-005-2525 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A07/16/2018
Labeler - Montani Cosmetics Inc (124852331)

Revised: 7/2018
Document Id: 714de9d8-ce2b-2274-e053-2995a90afdb0
Set id: 714de9d8-ce31-2274-e053-2995a90afdb0
Version: 1
Effective Time: 20180718
 
Montani Cosmetics Inc