FDA.reportPublic FDA data

Calendula Gel 2.6oz

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2023-03-16
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:20:32

Label at a glance#

ProductCalendula
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure15 sections

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Calendula officinalis 1X

INDICATIONS & USAGE SECTION

Helps promote healing of scrapes and skin irritations.

OTC - DO NOT USE SECTION

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

DOSAGE & ADMINISTRATION SECTION

For scrapes and skin irritations, 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 SECTION

Caprylyl glycol, carbomer, dimethicone copolyol, EDTA disodium, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

HOW SUPPLIED SECTION

Tube 2.6 OZ (75 G)

OTC - PURPOSE SECTION

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

STORAGE AND HANDLING SECTION

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

OTC - QUESTIONS SECTION

Questions, Comments?

www.boironusa.com

info@boironusa.com

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

Boiron Information Center
6 Campus Boulevard
Newtown Square, PA 19073-3267

OTC - ASK DOCTOR SECTION

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

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

DRUG INTERACTIONS SECTION

Non-greasy - Paraben-Free - Quickly absorbed - Cooling effect - Works naturally with your body

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

labellabellabellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-1108-592023-03-17C16284748780-19d75b9d0-9b53-f424-e053-dadaa90a57ceCalendula Gel 2.6oz
0220-1108-592023-01-30C16284748780-19d75b9d0-9b53-f424-e053-dadaa90a57ceCalendula Gel 2.6oz
0220-1108-592020-02-26C16284748780-19d75b9d0-9b53-f424-e053-dadaa90a57ceCalendula Gel 2.6oz
0220-1108-592020-01-31C16284748780-19d75b9d0-9b53-f424-e053-dadaa90a57ceCalendula Gel 2.6oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-1108-59Calendula75 g in 1 TUBEGEL757

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-1108CALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) GEL [LABORATOIRES BOIRON]7Current NDC, Legacy NDC, 1 package rows20230317_25764f5a-378b-4103-81a1-2a6309e3e8e1.zip

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
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O3
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K3
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 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-11080220-1108-59

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
DIMETHICONE92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBIC ACIDX045WJ989BIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB

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 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SORBIC ACIDSORBIC ACIDX045WJ989BGEL / TOPICAL2 mgExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalendulaCALENDULA OFFICINALIS FLOWERING TOPLaboratoires Boiron25764f5a-378b-4103-81a1-2a6309e3e8e12023-03-16WarningsExact identifier
ndc (package): 0220-1108-59
ndc (product): 0220-1108
ndc11 (package): 00220110859
spl id: f706dc04-987c-ee0d-e053-6394a90a3629
spl set id: 25764f5a-378b-4103-81a1-2a6309e3e8e1

Reported adverse events (FAERS/openFDA)#

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