Dermisa Skin Fade

Dosage form: cream
Ingredients: HYDROQUINONE 2g in 100g, PADIMATE O 0.6g in 100g
Labeler: Montani Cosmetics Inc
NDC Code: 68343-001

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.

Drug Facts

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 IngredientsWater, Glyceryl Monostearate, Mineral Oil, Propylene Glycol, Cetyl Alcohol, Dimethicone, Sodium Lauryl Sulphate, Disodium EDTA, Ascorbic Acid (Vitamin C), Sodium Metabisulphite, Propylparaben, Fragrance, Allantoin

Carton LabelPackage Label

DERMISA  SKIN FADE
hydroquinone padimate o cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68343-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROQUINONE (HYDROQUINONE) HYDROQUINONE2 g  in 100 g
PADIMATE O (PADIMATE O) PADIMATE O0.6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
MINERAL OIL 
GLYCERYL MONOSTEARATE 
PROPYLENE GLYCOL 
CETYL ALCOHOL 
DIMETHICONE 
SODIUM LAURYL SULFATE 
EDETATE DISODIUM 
ASCORBIC ACID 
SODIUM METABISULFITE 
PROPYLPARABEN 
ALLANTOIN 
Packaging
#Item CodePackage Description
1NDC:68343-001-011 TUBE (TUBE) in 1 BOX
1NDC:68343-001-5050 g in 1 TUBE
2NDC:68343-001-021 TUBE (TUBE) in 1 BOX
2NDC:68343-001-2525 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart358A09/15/2011
Labeler - Montani Cosmetics Inc (124852331)
Establishment
NameAddressID/FEIOperations
Cleanliness Ltd232500475manufacture

Revised: 05/2012
 
Montani Cosmetics Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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