FDA Label for Calendula
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- INDICATIONS & USAGE
- OTC - DO NOT USE
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- HOW SUPPLIED
- OTC - PURPOSE
- STORAGE AND HANDLING
- OTC - QUESTIONS
- OTC - ASK DOCTOR
- OTC - STOP USE
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - WHEN USING
- DRUG INTERACTIONS
- WARNINGS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Calendula Product Label
The following document was submitted to the FDA by the labeler of this product Laboratoires 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
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.