Fluid powder with anesthine
Poland
Table of Contents
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. COMPOSITION OF ACTIVE SUBSTANCES (YCH)
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND PACKAGING CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. WARNING REGARDING STORAGE OF THE MEDICINAL PRODUCT
- 7. OTHER SPECIAL WARNINGS, IF NECESSARY
- 8. EXPIRY DATE
- 9. STORAGE INSTRUCTIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 14. GENERAL AVAILABILITY CATEGORY
- 1. NAME OF THE MEDICINAL PRODUCT
- 2. ACTIVE SUBSTANCE CONTENT (YCH)
- 3. LIST OF EXCIPIENTS
- 4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
- 5. METHOD AND ROUTE(S) OF ADMINISTRATION
- 6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
- 7. OTHER SPECIAL WARNINGS, IF NECESSARY
- 8. EXPIRY DATE
- 9. STORAGE CONDITIONS
- 10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
- 11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
- 12. MARKETING AUTHORISATION NUMBER(S)
- 13. BATCH NUMBER
- 14. GENERAL AVAILABILITY CATEGORY
- 17. OTHER INFORMATION
INFORMATION ON THE IMMEDIATE PACKAGING
{Tube}
1. NAME OF THE MEDICINAL PRODUCT
PUDER PŁYNNY Z ANESTEZYNĄ
(240 mg + 20 mg)/g, cutaneous suspension
(Zinci oxidum + Benzocainum)
2. COMPOSITION OF ACTIVE SUBSTANCES (YCH)
Composition
1 g of the 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 CONTENTS
100 g
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Dosage and method of administration
For topical use.
The medicinal product should be applied to the affected skin areas two to three times daily.
Shake well before use.
6. WARNING REGARDING STORAGE OF THE MEDICINAL PRODUCT
KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine in a place out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
Precautions
Avoid contact of the medicinal product with eyes and mucous membranes.
Use with caution in young children (over 2 years of age).
If there is no improvement after several days of using the medicinal product, consult a physician.
8. EXPIRY DATE
Expiry date:
9. STORAGE INSTRUCTIONS
Storage conditions
Store below 25°C, in a tightly closed container, in a dry place.
Do not use the medicinal product after the expiry date stated on the packaging.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
MEDICINAL PRODUCT OR WASTE DERIVED FROM THE MEDICINAL PRODUCT, IF
APPLICABLE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Marketing Authorisation Holder
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
12. MARKETING AUTHORISATION NUMBER(S)
Authorisation Number R/6997
13. BATCH NUMBER
Batch number:
14. GENERAL AVAILABILITY CATEGORY
OTC - Medicinal product available without a prescription.
15. INSTRUCTIONS FOR USE
16. INFORMATION PROVIDED IN BRAILLE
17. OTHER
Indications
Topical medicinal product for application on the skin as an astringent, drying and anti-itch agent in
chickenpox, shingles, insect bites, urticaria and other skin diseases accompanied by itching.
Contraindications
Do not use the medicinal product:
- in hypersensitivity to zinc oxide, benzocaine or to any of the excipients;
- in exuding or渗ating skin lesions;
- on open wounds, large skin surfaces, or denuded skin;
- for prolonged periods;
- in children under 2 years of age due to the risk of methemoglobinemia (hemoglobin disorder).
Use with other medicinal products
No data available.
Pregnancy and breastfeeding
Consult a physician before use.
There are no data on the safety of use during pregnancy and breastfeeding.
Driving and operating machinery
No data on the influence of the medicinal product on the ability to drive and operate machinery.
Undesirable effects
Hypersensitivity reactions and local skin irritation may occasionally occur.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your physician.
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INFORMATION ON OUTER PACKAGING
{ cardboard box containing a 100 g tube }
1. NAME OF THE MEDICINAL PRODUCT
PUDER PŁYNNY Z ANESTEZYNĄ
(240 mg + 20 mg)/g, cutaneous suspension
(Zinci oxidum + Benzocainum)
2. ACTIVE SUBSTANCE CONTENT (YCH)
Composition
1 g of skin suspension contains:
active substances: 240 mg zinc oxide and 20 mg benzocaine,
3. LIST OF EXCIPIENTS
excipients: talc, glycerol, levomenthol, purified water.
4. PHARMACEUTICAL FORM AND PACKAGE CONTENTS
100 g EAN Code: 5909990682362
5. METHOD AND ROUTE(S) OF ADMINISTRATION
Dosage and method of administration
For topical use.
The medicinal product should be applied to the affected skin areas two to three times daily.
Shake well before use.
6. WARNING ON STORAGE OF THE MEDICINAL PRODUCT
KEEP OUT OF SIGHT AND REACH OF CHILDREN
Keep the medicine in a place out of sight and reach of children.
7. OTHER SPECIAL WARNINGS, IF NECESSARY
Precautions
Avoid contact of the medicinal product with eyes and mucous membranes.
Use with caution in young children (over 2 years of age).
If there is no improvement after several days of using the medicine, consult a doctor.
8. EXPIRY DATE
Expiry date
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9. STORAGE CONDITIONS
Storage conditions
Store below 25°C, in a tightly closed container, in a dry place.
Do not use the medicinal product after the expiry date stated on the packaging.
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED
MEDICINAL PRODUCT OR WASTE DERIVING FROM SUCH MEDICINAL PRODUCT, IF
APPLICABLE
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Marketing Authorisation Holder
"PRZEDSIĘBIORSTWO PRODUKCJI FARMACEUTYCZNEJ HASCO-LEK" S.A.
51-131 Wrocław, ul. Żmigrodzka 242 E
Tel. +48 (71) 352 95 22
Fax +48 (71) 352 76 36
e-mail: [email protected]
12. MARKETING AUTHORISATION NUMBER(S)
Authorisation number R/6997
13. BATCH NUMBER
Batch number
14. GENERAL AVAILABILITY CATEGORY
OTC - Medicinal product available without a prescription.
15. INSTRUCTIONS FOR USE
16. INFORMATION PROVIDED IN BRAILLE SYSTEM
puder płynny z anestezyną
17. OTHER INFORMATION
Indications
Topical medicinal product for skin application, with astringent, drying and antipruritic properties, in
chickenpox, shingles, insect bites, urticaria and other skin diseases accompanied by itching.
Contraindications
Do not use the medicinal product:
- in case of hypersensitivity to zinc oxide, benzocaine or any of the excipients;
- in exudative or渗ative skin lesions;
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- on open wounds, large skin surfaces, or on skin deprived of epidermis;
- for prolonged periods;
- in children under 2 years of age due to the risk of methemoglobinemia (abnormality of hemoglobin).
Use with other medicinal products
No data available.
Pregnancy and breastfeeding
Consult a physician before using this medicinal product.
There are no data on the safety of using this medicinal product during pregnancy and breastfeeding.
Driving and operating machinery
No data available on the influence of the medicinal product on the ability to drive or operate machinery.
Undesirable effects
Hypersensitivity reactions and local skin irritation may occasionally occur.
If any of the adverse effects worsen or if any adverse effects not listed in this leaflet occur, inform a physician immediately.
HASCO-LEK Logo
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