FDA Label for Calendula
View Indications, Usage & Precautions
Calendula Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. 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
Calendula Officinalis 1X HPUS
Indications & Usage
- Temporarily protects and helps promote healing of minor burns.
Otc - Do Not Use
Do not use
- Over large areas of the body
- If you are allergic to Calendula officinalis or to this product's inactive ingredients.
- Under tight bandages.
- Do not use if glued carton end flaps are broken or if the tube seal is broken.
Dosage & Administration
For minor burns, immediately run cool water on the burn for several minutes and dry.
- Then apply a thin layer of Calendula Burn to affected area 3 times a day or as needed.
Inactive Ingredient
White petrolatum NF
How Supplied
Tube 1 OZ (30 G)
Otc - Purpose
Calendula officinalis 1X ... Healing agent
Otc - Questions
Questions, Comments?
www.BoironUSA.com
[email protected]
1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron Inc.
6 Campus Boulevard
Newtown Square, PA
19073-3267
Otc - Ask Doctor
Ask a doctor before use in case of deep puncture wounds, animal bites or serious burns the present
- bisters
- thickening of the skin
- while and leathery appearance.
Otc - Stop Use
Stop use and ask a doctor if condition persists for more than 3 days or worsens or reoccurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children
Other
- Soothing Ointment
- Lidocaine Free
- Benzocaine Free
- Protects & Heals
Warnings
For external use only. Avoid contact with eyes.
If swallowed, get medical help or contact a Poison Control Center right away.
Package Label.Principal Display Panel
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