Otc - Active Ingredient
Calendula officinalis 1X
Calendula Cream
FDA Label NDC 0220-1109
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 0220-1109). 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, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Indications & Usage
Helps promote healing of minor burns and cuts, scrapes, skin irritations and sunburn.
Otc - Do Not Use
Do not use if glued carton en flaps are open or if the tube seal is broken.
Dosage & Administration
For minor burns, immediately run coll water on the burn for several minutes and dry. For scrapes and skin irritations, first cleanse the area with mild soap, rinse and dry.
Then apply a thin layer of Calendula cream to affected area 3 times a day or as needed.
Inactive Ingredient
Calendula Cream:
Caprylyl glycol, carbomer, cetyl palmitate, EDTA disodium, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol
Calendula Cream (without disodium EDTA)
Caprylyl glycol, carbomer, cetyl palmitate, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol
How Supplied
Tube 2.6 OZ (70 G)
Otc - Purpose
Calendula officinalis 1X ... Healing agent HPUS 10 %
Storage And Handling
Store at 68-77 O F (20-25 O C)
Otc - Questions
Questions, Comments?
www.boironusa.com
1-800-BOIRON-1 (1-800-264-7661)
Boiron Information Center
6 Campus Boulevard
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
Otc - Pregnancy Or Breast Feeding
Otc - When Using
Drug Interactions
Moisturizing - Paraben-Free - Ideal for sensitive skin - Works naturally with your body
Warnings
For external use only
Avoid contact with eyes.
If swallowed, get medical help or contact a Poison Control Center right away.
* Please review the disclaimer below.
