“Composition:
100 g of cream contains: Active ingredient: promethazine hydrochloride 2.25 g, which corresponds to 2.0 g of promethazine base. For a complete list of excipients, see section 6.1.
Excipients
Excipients: liquid paraffin, stearic acid, glycerin, triethanolamine, methyl p-hydroxybenzoate, propyl p-hydroxybenzoate, white wax, purified water, thiourea.
Therapeutic indications
Local symptomatic treatment of insect bites and other localized skin irritations such as redness, burning, itching and sunburn.
Contraindications
PROMETHAZINE NA is contraindicated in: – hypersensitivity to the active substance or to any of the excipients or to other chemically related substances; – eczema; – secreting lesions. PROMETHAZINE NA is contraindicated for children under 2 years of age.
Dosage
Apply the cream 2-3 times a day to the affected area. Avoid applying to very large areas exceeding 10% of the body surface. Do not exceed the recommended doses.
Warnings and precautions
Long-term and incorrect use of the drug may lead to allergic sensitization with subsequent worsening of symptoms. In this case, the treatment should be stopped and a doctor should be consulted to prescribe appropriate therapy. Since the use of PROMETHAZINE NA can slow down the healing process, the drug should not be used for more than 3-4 days in a row on the affected areas where this phenomenon occurs. In case of sunburn, apply the medicine and avoid further exposure of the irritated skin to sunlight. If skin rashes, irritation and burning occur, treatment should be stopped. Important information about some excipients: the product contains methyl p-hydroxybenzoate and propyl p-hydroxybenzoate, which may cause allergic reactions, even delayed ones.
Interactions
Interaction with other drugs for topical use is unknown.
Side effects
PROMETHAZINE NA may cause allergic reactions. The use of promethazine has been associated with photosensitivity reactions. Excessive application of the product to very large areas of skin may cause drowsiness.
Pregnancy and breastfeeding
Pregnant women should use the product only if absolutely necessary and under medical supervision.”
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