- Name of the medicinal product
Calamine Lotion USP (Taj Pharma)
- Qualitative and quantitative composition
| Active ingredients | ||
| Calamine | USP | |
| Zinc Oxide | USP | |
- Pharmaceutical form
Lotion
- Clinical particulars
4.1 Therapeutic indications
For the relief of minor skin rashes and irritation.
4.2 Posology and method of administration
Adults, children and elderly
To be applied when required to the affected area.
For topical application.
4.3 Contraindications
Hypersensitivity to any of the ingredients.
4.4 Special warnings and precautions for use
Shake the bottle.
For external use only.
Keep all medicines out of the reach of children.
4.5 Interaction with other medicinal products and other forms of interaction
No clinically significant interactions known.
May mask x-ray pictures under certain circumstances.
4.6 Pregnancy and lactation
The safety of Calamine Lotion during pregnancy and lactation has not been established but use during these periods is not considered to constitute a hazard.
4.7 Effects on ability to drive and use machines
No adverse effects known.
4.8 Undesirable effects
Occasional hypersensitivity or irritant reactions.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
4.9 Overdose
If ingested symptoms of overdosage include anorexia, nausea, vomiting, epigastric discomfort and diarrhoea. Treatment consists of symptomatic measures only.
- Pharmacological properties
5.1 Pharmacodynamic properties
Calamine has a mild astringent action on the skin.
5.2 Pharmacokinetic properties
None known.
5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that already included.
- Pharmaceutical particulars
6.1 List of excipients
Bentonite, Glycerol, Sodium Citrate, Phenol, Water Purified.
6.2 Incompatibilities
None stated.
6.3 Shelf life
12 months.
6.4 Special precautions for storage
None.
6.5 Special precautions for disposal and other handling
None stated.
7.Manufactured BY:
Taj Pharmaceuticals Ltd.
at: Plot. No. 220, Mahagujarat
Industrial Estate, At & Post-Moraiya,
Tal-Sanand, Dist- Ahmedabad Gujarat (India).
Calamine Lotion USP (Taj Pharma)
Patient information leaflet
Read all of this label for full instructions.
What this medicine is for
A mild astringent lotion for the relief of minor skin rashes and irritation.
Before you use this medicine
Do not use:
- If you are allergic to any of the ingredients
- If you are having an x-ray because it may affect the results)
You can use this medicine if you are pregnant or breastfeeding.
How to use this medicine
Check the cap seal is not broken before first use. If it is, do not use the lotion.
Shake the bottle before use.
Adults and children: Apply to the affected area when you need to.
For use on the skin only.
If symptoms do not go away talk to your doctor.
If anyone accidentally swallows some: Talk to a pharmacist or doctor.
Possible side effects
Most people will not have problems, but some may get some of these:
- Skin rash, red or itchy skin (allergic reaction)
- Skin irritation
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed on this label.
Keep all medicines out of the sight and reach of children.
Use by the date on the label edge.
Active ingredients
This lotion contains Calamine & Zinc Oxide
Also contains: purified water, glycerol, bentonite, sodium citrate, phenol.
7.Manufactured BY:
Taj Pharmaceuticals Ltd.
at: Plot. No. 220, Mahagujarat
Industrial Estate, At & Post-Moraiya,
Tal-Sanand, Dist- Ahmedabad Gujarat (India).
