Puder pvinni z anestezinom

INFORMATION PLACED ON DIRECT PACKAGING

{Tube}

1. NAME OF THE MEDICINAL PRODUCT

LIQUID POWDER WITH ANESTHESIN (240 mg + 20 mg)/g, suspension for the skin

(Zinci oxidum + Benzocainum)

2. CONTENT OF ACTIVE SUBSTANCES

Composition

1 g of skin suspension contains:
active substances:240 mg of zinc oxide and 20 mg of benzocaine,

3. LIST OF EXCIPIENTS

excipients:talc, glycerol, levomenthol, purified water.

4. PHARMACEUTICAL FORM AND PACKAGING CONTENT

100 g

5. METHOD AND ROUTE OF ADMINISTRATION

Dosage and administration

Application to the skin.
The drug should be applied to the diseased areas of the skin two to three times a day.
Shake before use.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INACCESSIBLE AND INVISIBLE TO CHILDREN

Store the medicine in a place inaccessible and invisible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Precautions

Avoid contact of the medicine with eyes and mucous membranes.
Use with caution in small children (over 2 years old).
In case of no improvement after a few days of using the medicine, consult a doctor.

8. EXPIRY DATE

Expiry date:

9. STORAGE CONDITIONS

Storage conditions

Store in a temperature below 25°C, in a tightly closed packaging, in a dry place.
Do not use the medicine after the expiry date stated on the packaging.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Marketing authorization holder

“HASCO-LEK” PHARMACEUTICAL MANUFACTURING COMPANY S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E

12. MARKETING AUTHORIZATION NUMBER(S)

Marketing authorization number R/6997

13. BATCH NUMBER

Batch number:

14. GENERAL CATEGORY OF AVAILABILITY

OTC - Medicine available without a prescription.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE SYSTEM

17. OTHER

Indications for use

Medicine for local application to the skin as a drying, astringent and anti-itch agent in eczema, dermatitis, after insect bites, urticaria and other skin diseases accompanied by itching.

Contraindications

Do not use the medicine:

• in hypersensitivity to zinc oxide, benzocaine or any excipient of the medicine;
• in weeping and exudative skin changes;
• on open wounds, large areas of skin, skin without epidermis;
• for a long time;
• in children under 2 years of age, due to the risk of methemoglobinemia (abnormality related to hemoglobin).

Interaction with other medicines

No data available.

Pregnancy and breastfeeding

Before using the medicine, consult a doctor.
No data available on the safety of using the medicine during pregnancy and breastfeeding.

Driving vehicles and operating machines

No data available on the effect of the medicine on the ability to drive vehicles and operate machines.

Undesirable effects

Sometimes, symptoms of hypersensitivity, local skin irritation may occur.
If any of the undesirable effects worsen or any undesirable effects not mentioned in the leaflet occur, consult a doctor.

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INFORMATION PLACED ON EXTERNAL PACKAGING {cardboard box containing 100g tube}

1. NAME OF THE MEDICINAL PRODUCT

LIQUID POWDER WITH ANESTHESIN (240 mg + 20 mg)/g, suspension for the skin

(Zinci oxidum + Benzocainum)

2. CONTENT OF ACTIVE SUBSTANCES

Composition

1 g of skin suspension contains:
active substances:240 mg of zinc oxide and 20 mg of benzocaine,

3. LIST OF EXCIPIENTS

excipients:talc, glycerol, levomenthol, purified water.

4. PHARMACEUTICAL FORM AND PACKAGING CONTENT

100 g EAN Code: 5909990682362

5. METHOD AND ROUTE OF ADMINISTRATION

Dosage and administration

Application to the skin.
The drug should be applied to the diseased areas of the skin two to three times a day.
Shake before use.

6. WARNING ABOUT STORAGE OF THE MEDICINAL PRODUCT

IN A PLACE INVISIBLE AND INACCESSIBLE TO CHILDREN

Store the medicine in a place invisible and inaccessible to children.

7. OTHER SPECIAL WARNINGS, IF NECESSARY

Precautions

Avoid contact of the medicine with eyes and mucous membranes.
Use with caution in small children (over 2 years old).
In case of no improvement after a few days of using the medicine, consult a doctor.

8. EXPIRY DATE

Expiry date

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9. STORAGE CONDITIONS

Storage conditions

Store in a temperature below 25°C, in a tightly closed packaging, in a dry place.
Do not use the medicine after the expiry date stated on the packaging.

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED PRODUCT OR WASTE DERIVED FROM IT, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORIZATION HOLDER

Marketing authorization holder

“HASCO-LEK” PHARMACEUTICAL MANUFACTURING COMPANY S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Phone: +48 (71) 352 95 22
Fax: +48 (71) 352 76 36
e-mail: informacjaoleku@haso-lek.pl

12. MARKETING AUTHORIZATION NUMBER(S)

Marketing authorization number R/6997

13. BATCH NUMBER

Batch number

14. GENERAL CATEGORY OF AVAILABILITY

OTC - Medicine available without a prescription.

15. INSTRUCTIONS FOR USE

16. INFORMATION PROVIDED IN BRAILLE SYSTEM

liquid powder with anesthesin

17. OTHER

Indications for use

Medicine for local application to the skin as a drying, astringent and anti-itch agent in eczema, dermatitis, after insect bites, urticaria and other skin diseases accompanied by itching.

Contraindications

Do not use the medicine:

• in hypersensitivity to zinc oxide, benzocaine or any excipient of the medicine;
• in weeping and exudative skin changes;

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• on open wounds, large areas of skin, skin without epidermis;
• for a long time;
• in children under 2 years of age, due to the risk of methemoglobinemia (abnormality related to hemoglobin).

Interaction with other medicines

No data available.

Pregnancy and breastfeeding

Before using the medicine, consult a doctor.
No data available on the safety of using the medicine during pregnancy and breastfeeding.

Driving vehicles and operating machines

No data available on the effect of the medicine on the ability to drive vehicles and operate machines.

Undesirable effects

Sometimes, symptoms of hypersensitivity, local skin irritation may occur.
If any of the undesirable effects worsen or any undesirable effects not mentioned in the leaflet occur, consult a doctor.

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