Dermisa description, usages, side effects, indications, overdosage, supplying and lots more!

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Dermisa

Montani Cosmetics Inc

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active Ingredient

Hydroquinone USP 2%
Octyl Dimethyl Paba 0.60%

Purpose




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

Carton Label


Dermisa

Dermisa

Hydroquinone Padimate O CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:68343-001
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Hydroquinone HYDROQUINONE 2 g
PADIMATE O PADIMATE O 0.6 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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68343-001-50 50 in 1 TUBE
2 NDC:68343-001-25 25 in 1 TUBE
3 NDC:68343-001-02 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partA part358A 2011-09-15


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