CALENDULA- calendula officinalis flowering top ointment

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 chapped hands and lips, and nasal irritations from colds.

Helps promote healing of minor burns, scrapes and cuts.

DO NOT USE

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

DOSAGE & ADMINISTRATION

For minor cuts, scrapes and chapped skin, first cleanse the area with mild soap, rinse and dry. For minor burns, immediately run cool water on the burn for several minutes and dry.
Then apply a thin layer of Calendula Ointment to affected area 3 times a day or as needed.

INACTIVE INGREDIENT

White petrolatum USP

HOW SUPPLIED

Tube 1 OZ (30 G)

PURPOSE

Calendula officinalis 1X ... Healing agent HPUS 4 %

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)

Distributed by Boiron Inc.
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

Keep wounds moisturized - Paraben-free - 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 ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-1104
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
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-1104-51	30 g in 1 TUBE; Type 0: Not a Combination Product	07/17/1988

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		07/17/1988

Labeler - Laboratoires Boiron (282560473)

Registrant - Boiron Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-1104)