FDA.reportPublic FDA data

Calendula Off. 1x

Manufacturer
Hyland's | Standard Homeopathic Company
Effective date
2017-07-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:14:31

Label at a glance#

ProductCalendula Off.
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure8 sections

Dosage and administration

Wash affected area with lukewarm water and apply freely as needed, or as recommended by a licensed health care provider.

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Minor Skin Irritations

Warnings

WARNINGS SECTION

For External Use Only.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of the reach of children.

OTC - ASK DOCTOR SECTION

If symptoms persist for more than seven days or worsen, consults a licensed health care professional.

OTC - DO NOT USE SECTION

Do not use if tamper evident seal is broken or missing.

Directions

DOSAGE & ADMINISTRATION SECTION

Wash affected area with lukewarm water and apply freely as needed, or as recommended by a licensed health care provider.

INACTIVE INGREDIENT SECTION

In a base of Petrolatum USP, with 5% Lanolin USP.

OTC - QUESTIONS SECTION

800/624-9659

OTC - ACTIVE INGREDIENT SECTION

CALENDULA OFFICINALIS 1x

OTC - PURPOSE SECTION

For the temporary symptomatic relief of skin irritations due to sunburn, windburn and chafing or diaper rash. Promotes healing of minor cuts and abrasions of the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54973-2052-09

Hyland's™

HOMEOPATHIC

Calendula

Off. 1x

Minor Skin Irritations

Homeopathic Ointment

13.5 OZ./405 GM.

11

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54973-205254973-2052-9, 54973-2052-3, 54973-2052-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HIACT
PETROLATUM4T6H12BN9UIACT
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
d43ab880-18d1-118a-e053-2995a90a50625563972b-6ea4-3c9d-e054-00144ff88e882021-12-28WarningsExact identifier
spl set id: 5563972b-6ea4-3c9d-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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