CALENDULA

Manufacturer
Boiron | Boiron Inc.
Effective date
2023-02-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:20:06

Label at a glance#

ProductCALENDULA
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure15 sections

Storage and handling

Store below 68-77° F (20-25° C)

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.

INDICATIONS & USAGE SECTION

  • Temporarily protects and helps promote healing of minor burns.

OTC - DO NOT USE SECTION

Do not use

  • Over large areas of the body
  • If you are allergic to Calendula officinalis or to this product's inactive ingredients.
  • Under tight bandages.
  • Do not use if glued carton end flaps are broken or if the tube seal is broken.

DOSAGE & ADMINISTRATION SECTION

For minor burns, immediately run cool water on the burn for several minutes and dry.

  • Then apply a thin layer of Calendula Burn to affected area 3 times a day or as needed.

INACTIVE INGREDIENT SECTION

White petrolatum USP, alcohol, purfied water

HOW SUPPLIED SECTION

Tube 1 OZ (30 G)

OTC - PURPOSE SECTION

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

STORAGE AND HANDLING SECTION

Store below 68-77° F (20-25° C)

OTC - QUESTIONS SECTION

Questions, Comments?

BoironCalendula.com

BoironUSA.com
info@boiron.com

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

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

OTC - ASK DOCTOR SECTION



Ask a doctor before use in case of deep puncture wounds, animal bites or serious burns that present

  • bisters
  • thickening of the skin
  • white and leathery appearance.

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

SPL UNCLASSIFIED SECTION

Soothes & Heals

Protects Skin

Plant-based relief

No fragrances, dyes or parabens

For all ages

Burn Relief*

Minor Burns*

ɨ 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.

WARNINGS SECTION

For external use only. Avoid contact with eyes.

If swallowed, get medical help or contact a Poison Control Center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabelCalendula Burn boxCalendula Burn box

Calendula Burn tubeCalendula Burn tube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-9086-512023-02-20C16284748780-1f386c649-e473-0266-e053-dadaa90a7c1aCalendula Burn
0220-9086-512023-01-30C16284748780-1f386c649-e473-0266-e053-dadaa90a7c1aCalendula Burn

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9086-51CALENDULA1 in 1 BOXOINTMENT14
0220-9086-51CALENDULA30 g in 1 TUBEOINTMENT304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9086CALENDULA OINTMENT [BOIRON]4Current NDC, Legacy NDC, 2 package rows20230221_28c76b61-2a0c-0f52-e054-00144ff8d46c.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-90860220-9086-51

Ingredients#

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

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

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CALENDULACALENDULABoiron28c76b61-2a0c-0f52-e054-00144ff8d46c2023-02-20WarningsExact identifier
ndc (package): 0220-9086-51
ndc (product): 0220-9086
ndc11 (package): 00220908651
spl id: f526b0db-d4fa-7281-e053-2995a90a6fa1
spl set id: 28c76b61-2a0c-0f52-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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