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

PURPOSE

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

INDICATIONS & USAGE

Helps promote healing of skin irritations such as: rashes, razor burns, insect bites or stings

WARNINGS

For external use only

Avoid contact with eyes.

ASK DOCTOR

Ask a doctor before use 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.

PREGNANCY OR BREAST FEEDING

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DO NOT USE

Do not use if you are allergic to Calendula officinalis or to any of this product's inactive ingredients.

DOSAGE & ADMINISTRATION

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, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

QUESTIONS

Questions, Comments?

BoironCalendula.com

BoironUSA.com

info@boironusa.com

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

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

SPL UNCLASSIFIED SECTION

Net Weight 1.5 oz. (45g)

Do not use if glued carton end flaps are open or if the tube seal is broken,

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

The letters "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Phatmacopoeia of the United States.

Natural Active Ingredient '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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CALENDULA 
calendula officinalis flowering top gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-1105
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)
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: 0220-1105-54	45 g in 1 TUBE; Type 0: Not a Combination Product	09/30/1993

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/30/1993

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-1105)