FDA.reportPublic FDA data

Calendula Gel 1.5oz

Manufacturer
Laboratoires Boiron | Boiron Inc. | Boiron
Effective date
2024-02-22
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:26:10

Label at a glance#

ProductCalendula
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure13 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients**

Calendula officinalis 1X HPUS 7%

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 7% ... Healing agent

INDICATIONS & USAGE SECTION

Uses*

helps promote healing of skin irritations such as:

  • rashes
  • razor burns
  • insect bites or stings

WARNINGS SECTION

For external use only. Avoid contact with eyes.

OTC - DO NOT USE SECTION

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

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 - 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

  • 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

alcohol, caprylyl glycol, carbomer, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

OTC - QUESTIONS SECTION

BoironCalendula.com

BoironUSA.com

info@boironusa.com

1-800-BOIRON-1

1-800-264-7661)

Distributed by Boiron, Inc.

Newtown Square, PA 19073

Made in France

SPL UNCLASSIFIED SECTION

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

store at 68-77 o F (20-25 o C)

Skin Irritations*

Rashes Razor Burn Insect Bites*

For all ages

1.5 oz (45 g)

*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

LabelLabelboxboxboxbox

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-1105-542023-03-17C16284748780-1f386c649-fed6-0266-e053-dadaa90a7c1aCalendula Gel 1.5oz
0220-1105-542023-01-30C16284748780-1f386c649-fed6-0266-e053-dadaa90a7c1aCalendula Gel 1.5oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-1105-54Calendula45 g in 1 TUBEGEL456

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-1105CALENDULA (CALENDULA OFFICINALIS FLOWERING TOP) GEL [LABORATOIRES BOIRON]6Current NDC, Legacy NDC, 1 package rows20240224_b775b879-6037-44a3-a5bd-045f2d923f3b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0220-1105-54GM - Gram0220-11050e7fd89f-22f1-4c64-8e14-cf07ae617b9612021-02-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ2
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ2
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1G2
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U2
CARBOMER HOMOPOLYMER TYPE CINACTIVE INGREDIENT4Q93RCW27E2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I2
SORBIC ACIDINACTIVE INGREDIENTX045WJ989B2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-11050220-1105-54

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CARBOMER HOMOPOLYMER TYPE C4Q93RCW27EIACT
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
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
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 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
CARBOMER HOMOPOLYMER TYPE CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EGEL / TOPICAL85 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
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

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 Boironb775b879-6037-44a3-a5bd-045f2d923f3b2024-02-22WarningsExact identifier
ndc (package): 0220-1105-54
ndc (product): 0220-1105
ndc11 (package): 00220110554
spl id: 11faf72e-0bc6-e598-e063-6394a90a8e06
spl set id: b775b879-6037-44a3-a5bd-045f2d923f3b

Reported adverse events (FAERS/openFDA)#

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