Label at a glance#

ProductCalendula

Active ingredientCALENDULA OFFICINALIS FLOWERING TOP

Label structure17 sections

Storage and handling

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

Contacts and useful links#

PhoneLabel contact1-800-264-7661

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Calendula officinalis 1X HPUS 4%

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Calendual officianlis 1X HPUS 4% .... Healing agent

INDICATIONS & USAGE SECTION

helps promote healing of: cuts, scrapes, minor burns, temporarily protects and helps relieve chafed, chapped, or cracked skin and lips, helps protect from the drying effects of wind and cold weather

OTC - DO NOT USE SECTION

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

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

DOSAGE & ADMINISTRATION SECTION

For minor burns, immediately run cool water on the burn for several minutes and pat dry. Then apply a thin layer of Calendula Ointment to affected area 3 times a day or as needed.

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

INACTIVE INGREDIENT SECTION

alcohol, purified water, white petrolatum USP

HOW SUPPLIED SECTION

Tube 1 OZ (30 G)

STORAGE AND HANDLING SECTION

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

OTC - QUESTIONS SECTION

Questions, Comments?

BoironCalendula.com

BoironUSA.com

Info@boironusa.com

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

Distributed by Boiron Inc.
Newtown Square, PA 19073-3267

OTC - ASK DOCTOR SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

OTC - WHEN USING SECTION

When using this product do not get into eyes

DRUG INTERACTIONS SECTION

Keep wounds moisturized - Paraben-free - Works naturally with your body

WARNINGS SECTION

For external use only

SPL UNCLASSIFIED SECTION

^†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.

Soothes & Heals

Protects Skin

Plant-Based Relief

First Aid*

Cuts, Scrapes, Minor Burns, Chapped Skin*

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelbox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0220-1104-51	2023-02-07	C162847	48780-1	9d75b9d0-e1dc-f424-e053-dadaa90a57ce	Calendula ointment
0220-1104-51	2023-01-30	C162847	48780-1	9d75b9d0-e1dc-f424-e053-dadaa90a57ce	Calendula ointment
0220-1104-51	2020-02-26	C162847	48780-1	9d75b9d0-e1dc-f424-e053-dadaa90a57ce	Calendula ointment
0220-1104-51	2020-01-31	C162847	48780-1	9d75b9d0-e1dc-f424-e053-dadaa90a57ce	Calendula ointment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0220-1104-51	Calendula	30 g in 1 TUBE	OINTMENT	30		6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0220-1104	CALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) OINTMENT [LABORATOIRES BOIRON]	6	Current NDC, Legacy NDC, 1 package rows	20230207_7cd204b9-6716-40ca-96d4-40758fb1ce1f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0220-1104-51	GM - Gram	0220-1104	50d8c513-d3a2-4002-b9a0-7de71f866677	1	2021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE INGREDIENT	18E7415PXQ	2
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE MOIETY	18E7415PXQ	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 5 matching rows.

Calendula
CALENDULA OFFICINALIS FLOWERING TOP
WATER
ALCOHOL
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0220-1104	0220-1104-51

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
ALCOHOL	3K9958V90M	IACT
PETROLATUM	4T6H12BN9U	IACT
CALENDULA OFFICINALIS FLOWERING TOP	18E7415PXQ	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calendula	CALENDULA OFFICINALIS FLOWERING TOP	Laboratoires Boiron	7cd204b9-6716-40ca-96d4-40758fb1ce1f	2023-02-06	Warnings	Exact identifier ndc (package): 0220-1104-51 ndc (product): 0220-1104 ndc11 (package): 00220110451 spl id: f40b2d36-692c-5803-e053-2a95a90af542 spl set id: 7cd204b9-6716-40ca-96d4-40758fb1ce1f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Calendula ointment