Indication:
U.S FDA APPROVED DRUGS FROM 01-01-08 TO 31-12-08
Drug name Indication Date of Approval
71.Hydroquinone 2% 31-01-08
+Tretinonin 0.025% (w/v)
+ Momentasone 0.10% Gel
For the short term intermittent treatment of moderate
to severe melasma of the face in the presence of
measures for sun avoidance including use of sun screen
Hyperpigmented skin
New drugs approved For Marketing by Drug Controller General of India(DCGI )
during the period January 1988 to November 2014
(Ref- IDMA Annual Publication 2015)
Name of Drug Indication Date of Approval
1.Hydroquinone 2% 31-01-2008
+Tretinoin 0.025%w/w
+ Momentasone 0.10% gel
For short term intermittant treatment of moderate to severe melasma
of the face in the presence of measures for sun avoidance including
use of sun screen
2.Hydroquinone 2% 23-02-2009
+ Tretionin 0.05%
+ Hydrocortisone 1% cream
For the treatment of patients with skin hyperpigmentation
3.Hydroquinone 20mg 23-02-2009
+ Tretionin 0.25mg
+ flucinolone acetonide 0.1mg per gm cream
For the treatment of melasma of face in adults
4.Hydroquinone USP 2% w/w 31-01-2011
+ Tretionin USP 0.25mg w/w
+ Allantoin USP 1%w/w gel
For the treatment of hyper pigmentary disorders
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
1.Hydroquinone 20mg + 23-02-2009
Tretionoin 0.25mg +
Fluocinolone acetonide 0.1mg per gm cream
2. Hydroquinone USP 2% w/w + 31-01-2011
Tretinoin USP 0.025% w/w +
Allantoin USP 1% w/w gel
For the treatment of hyper pigmentary disorders
3.Hydroquinone 20mg 23-02-2009
+ Tretionin 0.25mg
+ flucinolone acetonide 0.1mg per gm cream
For the treatment of melasma of face in adults
4.Hydroquinone USP 2% w/w 31-01-2011
+ Tretionin USP 0.25mg w/w
+ Allantoin USP 1%w/w gel
For the treatment of hyper pigmentary disorders
Contra-Indications:
Hypersensitivity to hydroquinone
Special Precautions/Warnings-
Bleaching- hydroquinone is a skin bleaching agent which may produce unwanted cosmetic effects if not used as directed
Irritation- to evalutate possibility to irritation or sensitivity each patient should start by applying the medication to a small portion of unbroken skin at or near the pigmented area over a period of several days. If no irritation occurs within 24 hours, begin treatment .
Minor redness is not necessarily a contraindication.
Sun exposure- during the depigmentation maintenance treatment, subsequent to intensive
depigmentation therapy sun exposure of the bleached skin should be avoided to prevent
repigmentation.
For external use only- avoid contact with eyes. In case of accidental contact, patient should rinse eyes throughly with water and contact physician. A bitter taste and antiseptic effect may occur if applied to the lips.
Sensitivity- A mild transient stinging may occur in people with sensitive skin. Do not use on
broken or irritated skin.
Peroxide- concurrent use of peroxide may result in transient dark staining of the skin due to oxidation by hydroquinone . Staining can be removed by discontinuing concurrent use and by normal soap cleaning.
Pregnancy- Should be used only if required.Consult a physician if you are pregnant or intend to become pregnant within 3 months.Follow your doctors advice.
Lactation- caution is adviced when topical hydroquinone is used by a nursing mother.
Children- Data not established. Not recommended for children below 12 years of age
Manufacturer Details