CALENDULA- calendula officinalis flowering top gel

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 scrapes and skin irritations.

DO NOT USE

Do not use if glued carton en flaps are open or if the tube seal is broken.

DOSAGE & ADMINISTRATION

For scrapes and skin irritations, first cleanse the area with mild soap, rinse and dry. Then apply a thin layer of Calendula Gel to affected area 3 times a day or as needed.

INACTIVE INGREDIENT

Caprylyl glycol, carbomer, dimethicone copolyol, EDTA disodium, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

HOW SUPPLIED

Tube 2.6 OZ (75 G)

PURPOSE

Calendula officinalis 1X ... Healing agent HPUS 7 %

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, or animal bites.

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

Non-greasy - Paraben-Free - Quickly absorbed - Cooling effect - 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 gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-1108
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
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBIC ACID (UNII: X045WJ989B)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-1108-59	75 g in 1 TUBE; Type 0: Not a Combination Product	04/13/1990

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		04/13/1990

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-1108)