1. Name of the medicinal product

Calamine Lotion USP (Taj Pharma)

  1. Qualitative and quantitative composition
Active ingredients
CalamineUSP
Zinc OxideUSP
  1. Pharmaceutical form

Lotion

  1. 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.

  1. 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.

  1. 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).