CALENDULA- calendula officinalis flowering top cream

Calendula by

Drug Labeling and Warnings

Calendula by is a Homeopathic medication manufactured, distributed, or labeled by Laboratoires Boiron, Boiron Inc., Boiron. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Calendula officinalis 1X

INDICATIONS & USAGE

Helps promote healing of  minor burns and cuts, scrapes, skin irritations and sunburn.

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)

PURPOSE

Calendula officinalis 1X ... Healing agent HPUS 10 %

STORAGE AND HANDLING

Store at 68-77 O F (20-25 O C)

QUESTIONS

Questions, Comments?

www.boironusa.com

info@boironusa.com

1-800-BOIRON-1 (1-800-264-7661)

Boiron Information Center
6 Campus Boulevard
Newtown Square, PA 19073-3267

ASK DOCTOR

Consult a doctor in case of deep or puncture wounds, animal bites or serious burns.

STOP USE

Stop use and ask doctor if condition persists for more than 3 days or worsens.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

PREGNANCY OR BREAST FEEDING

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALENDULA 
calendula officinalis flowering top cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-1109
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
HYDROGENATED PALM/PALM KERNEL OIL PEG-6 ESTERS (UNII: 8EPU9MJ01K)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERIN (UNII: PDC6A3C0OX)
PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-1109-63	70 g in 1 TUBE; Type 0: Not a Combination Product	03/21/2006
2	NDC: 0220-1109-68	1 in 1 BOX	02/29/2016
2		14 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/21/2006

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-1109)