Weleda Calendula Cuts and Grazes Skin Salve Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

TINCTURE FROM CALENDULA OFFICINALIS L., HERBA

Available from:

Weleda (UK) Limited

INN (International Name):

TINCTURE FROM CALENDULA OFFICINALIS L., HERBA

Dosage:

.

Pharmaceutical form:

Ointment

Prescription type:

Product not subject to medical prescription

Authorization status:

Marketed

Authorization date:

2017-07-28

Patient Information leaflet

I/708536/1
CONTINUES
OVER PAGE
WELEDA CALENDULA CUTS & GRAZES SKIN SALVE OINTMENT
READ THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU. KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN.
Ask your qualified healthcare practitioner or healthcare professional
eg a doctor
or pharmacist if you need more information or advice.
You must talk to a doctor if you feel worse, or do not feel better
after seven days. If
you get any side effects, talk to your qualified healthcare
practitioner or healthcare
professional eg a doctor or pharmacist. This includes any possible
side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What this product is and what it is used for
2. What you need to know before using this product
3. How to use this product
4. Possible side effects
5. How to store this product
6. Contents of the pack and other information
WELEDA CALENDULA CUTS & GRAZES SKIN SALVE OINTMENT IS A TRADITIONAL
HERBAL MEDICINAL PRODUCT USED FOR THE TREATMENT OF MINOR WOUNDS, CUTS
AND
GRAZES. THIS
IS
BASED
ON
TRADITIONAL
USE
ONLY.
EXCLUSIVELY
BASED
ON
LONGSTANDING USE. WELEDA CALENDULA CUTS & GRAZES SKIN SALVE OINTMENT
CONTAINS THE ACTIVE SUBSTANCE CALENDULA TINCTURE.
• DO NOT USE

if you are allergic to any of the ingredients or to plants of the
Asteraceae
(Compositae) family (see Section 6)
• WARNINGS AND PRECAUTIONS:
 avoid contact with the eyes and mucous membranes
 in some patients Weleda
Calendula Cuts & Grazes Skin Salve
Ointment
may
cause irritation to the skin when first applied. If you experience any
redness,
itching or dry skin discontinue use and consult your
qualified healthcare
practitioner or healthcare professional eg a doctor or pharmacist
 Weleda
Calendula Cuts & Grazes Skin Salve Ointment
is for use on the skin only
 do not expose affected areas to UV light during treatment e.g.
sunlight,
sunbeds
 if you notice any signs of skin infection you should consult your
qualified
healthcare practitioner or healthcare professional eg a doctor o

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Weleda Calendula Cuts and Grazes Skin Salve Ointment
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1g of ointment contains:
0.20 ml of tincture from_ Calendula officinalis_ L., herba (Calendula
herb) (equivalent to 100 mg of Calendula herb).
Extraction solvent: Ethanol 86 % w/w.
Excipients with known effect:
1g of ointment contains 324 mg of Wool Fat (Lanolin)
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Ointment.
A smooth, soft, cream to pale yellow ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
A traditional herbal medicinal product used for minor wounds, cuts and
grazes. Exclusively based on long standing use.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For cutaneous use only
Adults, the elderly and children over 6 years:
Wash hands before and after use.
Clean the affected area and apply to the affected area directly or on
a dry dressing two to three times daily.
Duration of use
Do not use for more than one week.
If symptoms worsen, persist or do not improve after one week of use of
Weleda Cuts & Grazes Skin Salve Ointment a
qualified healthcare practitioner or health care professional eg a
doctor or pharmacist should be consulted.
The use is not recommended in children under 6 years of age (See
section 4.4 Special Warnings and Precautions for
Use)
4.3 CONTRAINDICATIONS
Hypersensitivity to Calendula officinalis,
other species of the Asteraceae (Compositae) family or any of
the other
ingredients of the product listed in section 6.1.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Do not exceed the stated dose.
Since no data on the safe use in children are available, the use in
children under 6 years of age is not recommended.
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