FDA Label for Cicatrisan Cream
View Indications, Usage & Precautions
Cicatrisan Cream Product Label
The following document was submitted to the FDA by the labeler of this product Seroyal Usa. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients
This preparation contains:
Balsamum peruvianum
(Peruvian balsam) Balsam MT 1.0%
Bryonia dioica (Red bryony)
Root MT 1.0%
Calendula officinalis
(Marigold) Aerial Parts MT 1.0%
Dulcamara (Bittersweet)
Shoots MT 1.0%
Phytolacca decandra
(Pokeweed) Root MT 1.0%
Otc - Purpose
Uses
For the temporary relief of symptoms
associated with minor skin irritations.
Warnings
Warnings
For external use only.
Stop use and ask a doctor if symptoms
persist or worsen.
If pregnant or breastfeeding, ask a
health professional before use. Keep out
of reach of children. If swallowed, get
medical help or contact a Poison Control
Center right away.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
If swallowed, get medical help or contact a Poison
Control Center right away.
Inactive Ingredient
Inactive ingredients
Boric acid, mineral oil, sorbitan
sesquioleate, white petrolatum
Dosage & Administration
Directions
Adults: Apply a small amount on the
affected area two to three times daily, or as
recommended by your healthcare
practitioner. May cover affected area with
sterile gauze after each application.
Children: Use under the direction of your
healthcare practitioner.
Indications & Usage
Uses
For the temporary relief of symptoms
associated with minor skin irritations.
Directions
Adults: Apply a small amount on the
affected area two to three times daily, or as
recommended by your healthcare
practitioner. May cover affected area with
sterile gauze after each application.
Children: Use under the direction of your
healthcare practitioner.
Other Safety Information
Other information
Do not use if inner seal is missing or
broken.
Store in a cool, dry place.
Contents may not fill package in order to
accommodate required labeling. Please
rely on stated quantity
Package Label.Principal Display Panel
NDC 62106-3152-0
UNDA topicals
CICATRISAN CREAM
Homeopathic Preparation
For the temporary relief of symptoms
associated with minor skin irritations.
Net Weight 1.4 oz. (40 g)
* Please review the disclaimer below.