Otc - Active Ingredient
Calendula officinalis 1X HPUS 4%
The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.
Calendula Ointment
FDA Label NDC 0220-1104
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Laboratoires Boiron for the product Calendula (NDC 0220-1104). 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, indications & usage, otc - do not use, dosage & administration, inactive ingredient, how supplied, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Calendual officianlis 1X HPUS 4% .... Healing agent
Indications & Usage
helps promote healing of: cuts, scrapes, minor burns, temporarily protects and helps relieve chafed, chapped, or cracked skin and lips, helps protect from the drying effects of wind and cold weather
Otc - Do Not Use
Do not use if glued carton end flaps are open or if the tube seal is broken.
Do not use if you are allergic to Calendula officinalis or to any of this product's inactive ingredients
Dosage & Administration
For minor burns, immediately run cool water on the burn for several minutes and pat dry. Then apply a thin layer of Calendula Ointment to affected area 3 times a day or as needed.
For cuts, scrapes, and chapped skin, first cleanse the area with mild soap, rinse and dry. Then apply a thin layer of Calendula Ointment to affected area 3 times a day or as needed.
Inactive Ingredient
alcohol, purified water, white petrolatum USP
How Supplied
Tube 1 OZ (30 G)
Storage And Handling
Store at 68-77 O F (20-25 O C)
Otc - Questions
Questions, Comments?
BoironCalendula.com
BoironUSA.com
1-800-BOIRON-1 (1-800-264-7661)
Distributed by Boiron Inc.
Newtown Square, PA 19073-3267
Otc - Ask Doctor
Consult a doctor in case of deep or puncture wounds, animal bites or serious burns.
Otc - Stop Use
Stop use and ask doctor if condition persists for more than 3 days or worsens.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
Otc - When Using
When using this product do not get into eyes
Drug Interactions
Keep wounds moisturized - Paraben-free - Works naturally with your body
Warnings
For external use only
Other
†Homeopathic mother tincture made from Calendula officinalis flowering tops.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
Soothes & Heals
Protects Skin
Plant-Based Relief
First Aid*
Cuts, Scrapes, Minor Burns, Chapped Skin*
* Please review the disclaimer below.
