DERMISA SKIN FADE- hydroquinone 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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Drug Facts

Active Ingredient

Hydroquinone USP 2%
Octyl Dimethyl Paba 0.60%

Purpose

Skin Lightener
Sunscreen

Use


Warnings

Keep out of reach of children

Directions


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

Package Label

image of package label

DERMISA  SKIN FADE
hydroquinone padimate o cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68343-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (UNII: XV74C1N1AE) (HYDROQUINONE - UNII:XV74C1N1AE) HYDROQUINONE2 g  in 100 g
PADIMATE O (UNII: Z11006CMUZ) (PADIMATE O - UNII:Z11006CMUZ) PADIMATE O0.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68343-001-011 in 1 BOX09/15/2011
1NDC:68343-001-5050 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:68343-001-021 in 1 BOX09/15/2011
2NDC:68343-001-2525 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 finalpart358A09/15/2011
Labeler - Montani Cosmetics Inc (124852331)

Revised: 7/2018
Document Id: 71653743-e77e-90b0-e053-2995a90a1e98
Set id: 03fff226-a013-4a71-926e-5df3661be22e
Version: 5
Effective Time: 20180719
 
Montani Cosmetics Inc