FDA.reportPublic FDA data

Calendula Cream 2.5oz, 0.5oz, 0.18oz

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2025-12-09
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 02:35:44

Label at a glance#

ProductCalendula
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient**

Calendula officinalis 1X HPUS 10%

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

OTC - PURPOSE SECTION

Purpose*

Calendula officinalis 1X HPUS 10% ... Healing agent

INDICATIONS & USAGE SECTION

  • helps promote healing of minor:
  • cuts
  • scrapes
  • chafing
  • burns
  • sunburn
  • protects skin

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product

  • do not get into eyes
  • avoid diaper area

OTC - ASK DOCTOR SECTION

Ask a doctor before use 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 - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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 Cream to affected area 3 times a day.

For cuts, scrapes, chafed skin, and sunburn, first cleanse the area with mild soap, rinse, and pat dry. Then apply a thin layer of Calendula Cream to affected area 3 times a day.

INACTIVE INGREDIENT SECTION

arachidyl alcohol, arachidyl glucoside, behenyl alcohol, Butyrospermum parkii (Shea) butter, coconut oil, glycerin, lactobacillus ferment, purified water, xanthan gum

OTC - QUESTIONS SECTION

Questions, Comments?

BoironCalendula.com BoironUSA.com

Info@Boiron.com

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


Made in France
Distributed by Boiron, Inc.
Newtown Square, PA 19073

SPL UNCLASSIFIED SECTION

do not use if pouch is torn or open

dispose of 1 day after opening (0.18 oz / 5g)

do not use if glued carton end flaps are open

dispose of 1 day after opening (2.6 OZ / 70 G)

Pouch 0.18 OZ (5g)

Tube 2.6 OZ (70 G)

Tube 0.5 OZ (14 G)

FIRST AID*

Cuts Scrapes Minor Burns Sunburn*

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LABELLABELLABELLABEL

LABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABELLABEL

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130306962043568GTIN-13: 0306962043568
EAN-13: 0306962043568
GTIN-12: 306962043568
UPC-A: 306962043568
GTIN storage (14 digits): 00306962043568		Calendula Cream 2.5 oz BiDirect ETU.1FTV 04.2020.jpg
BarcodeEAN-130306969021699GTIN-13: 0306969021699
EAN-13: 0306969021699
GTIN-12: 306969021699
UPC-A: 306969021699
GTIN storage (14 digits): 00306969021699		Calendula Cream 0.5 oz ETU.1EN8 01.2020.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-1109-632020-02-26C16284748780-19d75b9d0-aa7a-f424-e053-dadaa90a57ceCalendula Cream 2.5oz, 0.5oz, 0.18oz
0220-1109-632020-01-31C16284748780-19d75b9d0-aa7a-f424-e053-dadaa90a57ceCalendula Cream 2.5oz, 0.5oz, 0.18oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-1109-63Calendula70 g in 1 TUBECREAM7012
0220-1109-68Calendula1 in 1 BOXCREAM112
0220-1109-68Calendula14 g in 1 TUBECREAM1412
0220-1109-93Calendula5 g in 1 POUCHCREAM512

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0220-1109-63GM - Gram0220-11095d8b143b-02aa-47ac-b354-e5ae259cbad712021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ3
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ3
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1G3
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U3
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E3
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08X3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
GLYCERININACTIVE INGREDIENTPDC6A3C0OX3
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VP3
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X53
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I3
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B3
WATERINACTIVE INGREDIENT059QF0KO0R3

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-11090220-1109-63, 0220-1109-68, 0220-1109-93

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
XANTHAN GUMTTV12P4NEEIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
DOCOSANOL9G1OE216XYIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
COCONUT OILQ9L0O73W7LIACT
LIMOSILACTOBACILLUS FERMENTUM2C1F12C6APIACT

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 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
CETYL PALMITATECETYL PALMITATE5ZA2S6B08XCREAM / TOPICAL0.32 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BCREAM / TOPICAL14 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32ICREAM / TOPICAL69 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
PEGOXOL 7 STEARATEPEGOXOL 7 STEARATE3EW5AXE5X5CREAM / TOPICAL640 mgExact identifier — unii+route+dosage form
4 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalendulaCALENDULA OFFICINALIS FLOWERING TOPLaboratoires Boiron2ed51803-5ec2-4163-ad12-2bf441551f072025-12-09WarningsExact identifier
ndc (package): 0220-1109-63
ndc (package): 0220-1109-93
ndc (package): 0220-1109-68
ndc (product): 0220-1109
ndc11 (package): 00220110993
ndc11 (package): 00220110968
ndc11 (package): 00220110963
spl id: 4588cfcf-6681-7206-e063-6394a90a4d6c
spl set id: 2ed51803-5ec2-4163-ad12-2bf441551f07

Reported adverse events (FAERS/openFDA)#

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