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
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
|
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 |
|
|
PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!