Indication:
Sunburn, prickly heat, insect bites, pruritus and allergy
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.Calamine 8% + Liquid paraffin 10% lotion 26-02-2009
As antipruritic and smoothering agent
2. Each ml contains calamine 15% w/v + 08-05-2009
Zinc oxide 5% + Bentonite 3% w/v +
glycerin 5%w/v + Sodium citrate 0.5%w/v
lotion
For the treatment of pruritis and prickly heat
FIXED DOSE COMBINATIONS APPROVED BY DCG(I)
FROM JANUARY 1961 TILL NOVEMBER 2014
Name of Drug Indication Date of Approval
.Calamine 8%+
Liquid Paraffin 10%Lotion 26-02-2009
As antipruritic and smoothing agent
Contra-Indications:
Blistered , raw or oozing areas of skin, mucous membrane
Special precautions:
Discontinue if burning occurs.
Dosages/ Overdosage Etc:
Indication-
Sunburn, prickly heat, insect bites, pruritus and allergy
Dosage-
Apply on affected area
Patient Information:
Calamine- Topical
1.Allergies-
Tell your doctor if you are have ever had any unusual or allergic reaction to
Calamine Also tell your healthcare care professional if you are allergic to any other
substances such as foods. preservatives or dyes.
2.Pregnancy-
Calamine has not shown to cause birth defects or other problems in humans
3. Breast-feeding-
Calamine has not been reported to cause problems in nursing babies.
4.Children-
Although there is no specific information comparing use of calamine in children
with use in other age groups, it is not expected to cause different side effects
or problems in children than it does in adults.
5.Older adults-
Many medicines have not been studied specifically in older people. Therefore,
it may not be known whether they work exactly the same way they do in younger
adults. Although there is no specific information comparing calamine in the elderly
with use in other age groups, this medicine is not expected to cause different side
effects or problems in older people than it does in younger adults.
6. Other medicines-
Although certain medicines should not be used together at all, in other cases two
different medicines may be used together even if an interaction might occur. in such
cases your doctor may want to change the dose, or other precautions may be necessary.
Tell your doctor if you are using any other topical prescription of prescription or
non-prescription (Over-the counter) OTC medicine that is to be applied to the same
area of the skin.