The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Cicatrisan Cream (NDC 62106-3152). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, overdosage, inactive ingredient, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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%
Uses
For the temporary relief of symptoms
associated with minor skin irritations.
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.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison
Control Center right away.
Inactive ingredients
Boric acid, mineral oil, sorbitan
sesquioleate, white petrolatum
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.
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 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
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.
