FDA.reportPublic FDA data

Calendula officinalis

Manufacturer
Heavenly Herbals, Inc.
Effective date
2024-05-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:03:29

Label at a glance#

ProductCalendula officinalis
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure10 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Calendula Officinalis Ø=1X
Calendula Officinalis Flowering Top)

Purpose

OTC - PURPOSE SECTION

Promotes the healing of injured skin.

Dosage

DOSAGE & ADMINISTRATION SECTION

Unless otherwise prescribed, adults take 5-10 drops mixed with water, 2-3 times daily. For children under the age of 12, consult your physician.

Indications

INDICATIONS & USAGE SECTION

Promotes the healing of injured skin.

Warning and Precautions

WARNINGS AND PRECAUTIONS SECTION

Contact physician if symptoms persist or worsen.

if pregnant or breast-feeding, consult a health professional before use.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Store at room temperature.

Protect from direct sun-light and heat.

Particulate matter is common in the extract.

Children

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 immediately.

Do Not Use

OTC - DO NOT USE SECTION

Do not use this product if clear shrink band is missing.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol 45% by volume.

Warning

WARNINGS SECTION

Contact physician if symptoms persist or worsen.

if pregnant or breast-feeding, consult a health professional before use.

In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Store at room temperature.

Protect from direct sun-light and heat.

Particulate matter is common in the extract.

Packaging Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84292-27084292-270-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB

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
31c064d5-4b06-0140-e063-6294a90a8ecc17a1aa66-524b-4565-e063-6394a90a42922025-04-01WarningsExact identifier
spl set id: 17a1aa66-524b-4565-e063-6394a90a4292

Reported adverse events (FAERS/openFDA)#

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