FDA Label for Arnica Cream
View Indications, Usage & Precautions
Arnica 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
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%
Otc - Purpose
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
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.
Otc - Keep Out Of Reach Of Children
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.
If swallowed, get medical help or contact a Poison
Control Center right away.
Inactive Ingredient
Inactive ingredients
Cetostearyl alcohol, glycerin, purified water, rose oil
Inactive ingredients
Cetostearyl alcohol, glycerin, purified water
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
Other information
Do not use if inner seal is missing or
broken.
Store in a cool, dry place.
Dosage & Administration
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.
Indications & Usage
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.
Package Label.Principal Display Panel
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.