Otc - Active Ingredient
Calendula Officinalis 1X HPUS
Calendula Ointment
FDA Label NDC 0220-9086
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Calendula (NDC 0220-9086). 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, indications & usage, otc - do not use, dosage & administration, inactive ingredient, how supplied, otc - purpose, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Calendula Burn Box (Calendula Burn Box)
Calendula Burn Tube (Calendula Burn Tube)
* Please review the disclaimer below.
