The following Structured Product Label (SPL) was submitted to the FDA by Seroyal Usa for the product Arnica Cream (NDC 62106-1180). 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, other safety information, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active ingredients
Calendula officinalis (Marigold) Aerial Parts MT 5.0%
Active ingredients
This preparation contains:
Arnica montana (Mountain arnica)
Aerial Parts MT 5.0%
Calendula officinalis (Marigold)
Aerial Parts MT 2.0%
Uses
For the temporary relief of symptoms associated with minor cuts and burns
Uses
For the temporary relief of symptoms associated with
minor sprains and bruises.
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.
Warnings
For external use only.
Do not use
on irritated skin
if excessive irritation develops
When using this product, avoid getting
into eyes or mucous membranes.
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.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison
Control Center right away.
If swallowed, get medical help or contact a Poison
Control Center right away.
Inactive ingredients
Cetostearyl alcohol, glycerin, purified water, rose oil
Inactive ingredients
Cetostearyl alcohol, glycerin, purified water
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
Other information
Do not use if inner seal is missing or
broken.
Store in a cool, dry place.
Directions
Adults: Apply a small amount on the affected area two to three times daily, or as
recommended by your healthcare practitioner.
Children: Use under the direction of your healthcare practitioner.
Directions
Adults: Apply a small amount on the affected
area two to three times daily, or as
recommended by your healthcare practitioner.
Children: Use under the direction of your
healthcare practitioner.
Uses
For the temporary relief of symptoms associated with minor cuts and burns
Directions
Adults: Apply a small amount on the affected area two to three times daily, or as
recommended by your healthcare practitioner.
Children: Use under the direction of your healthcare practitioner.
Uses
For the temporary relief of symptoms associated with minor sprains and bruises.
Directions
Adults: Apply a small amount on the affected
area two to three times daily, or as
recommended by your healthcare practitioner.
Children: Use under the direction of your
healthcare practitioner.
NDC 62106-1177-0
UNDA topicals
CALENDULA CREAM
Homeopathic Preparation
For the temporary relief of symptoms
associated with minor cuts and burns.
Net Weight 1.4 oz (40 g)
NDC 62106-1180-0
UNDA topicals
ARNICA CREAM
Homeopathic Preparation
For the temporary relief of symptoms associated
with minor sprains and bruises.
Net Weight 1.4 oz. (40 g)
* Please review the disclaimer below.
