Herbs for wound healing – product information

OUTER LABELLING

CARDBOARD BOX

Herbs for wound healing

Species advulnantes

Composition:

Melilot herb (Meliloti herba)   – 0.5 g | Oak bark (Quercus cortex) – 0.5 g

St. John's wort herb (Hyperici herba)         – 0.4 g

Arnica flower head (Arnicae anthodium)        – 0.3 g

Yarrow herb (Millefolii herba)      – 0.3 g

Herbs for brewing in sachets.

30 sachets, 2.0 g each

EAN UCC: 5909990021925

Indications for use:

Astringent properties, used in minor scrapes of the epidermis and scratches.

Method of administration: On skin.

Posology:

2 sachets, pour a glass of water and slowly heat up to boiling point, do not boil. Leave covered for 10-15 minutes.

Use externally for washes or poultices. Remove poultices after 20-30 minutes, do not leave for longer.

Do not use for occlusive poultices or cover with impermeable materials.

Contraindications:

Hypersensitivity to arnica or other plants from the composite family (Compositae/Asteraceae) and to other ingredients.

Warnings and precautions:

In case an allergic reaction, e.g. redness in spot where product was applied, is observed, use should be discontinued. Do not apply to open wounds.

Interactions:

None observed.

Pregnancy and lactation:

No safety data.

Impact on ability to drive vehicles and operate machinery:

None.

Adverse effects:

Longer use for wounds, ulcerations may cause eczema and toxic skin reactions, dermatitis with edema and forming of blisters.

Reporting adverse effects:

In case of any adverse effect, including those not stated on the packaging, notify a doctor, pharmacist or nurse. Adverse effects can be reported directly to the Department of Adverse Drug Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warszawa, tel.: 22 49-21-301,
fax: 22 49-21-309, e-mail: ndl@urpl.gov.pl.

Adverse effects can also be reported to the marketing authorization holder. Reporting adverse effects allows for more safety information to be gathered on a medicinal product.

Overdose:

None observed.

Dose omission:

Do not use double doses to supplement omitted doses.

Storage:

Store closed in max. 25° C

Keep away from children.

Marketing authorization holder:

Laboratorium Farmaceutyczne Labofarm Sp. z o.o.

ul. Lubichowska 176 b

83-200 Starogard Gdański

tel. 58 561 20 08

e-mail: poczta@labofarm.com.pl

Marketing authorization number: IL-5984/LN

Batch number:

Expiry date:

Do not use after expiry date.

Non-prescription medicinal product – OTC

Date of information approval: 09.11.2016