FDA.reportPublic FDA data

BM Calendula Ointment

Manufacturer
BM Private Limited
Effective date
2026-02-12
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:37:33

Label at a glance#

ProductBM Calendula
Active ingredientALOE VERA LEAF, CALENDULA OFFICINALIS FLOWERING TOP, CHAMOMILE
Label structure9 sections

Storage and handling

Storage: Store in a cool, dry place below 30°C (86°F). Protect from direct sunlight.

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Cetostearyl alcohol, Paraffin oil, White soft paraffin, Jasmine Fragrance

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Aloe Vera Ø (HPUS)

Calendula Ø (HPUS)

Chamomilla Ø (HPUS)

INDICATIONS & USAGE SECTION

Uses*

Helps temporarily relieve: skin irritation, rash, redness, minor wounds and burns, minor skin allergy

OTC - PURPOSE SECTION

Active ingredients Purpose*

Aloe Vera Ø (HPUS)……………. minor burns & skin irritation

Calendula Ø (HPUS)……………minor cuts & scrapes

Chamomilla Ø (HPUS)…………….itching & irritation

DOSAGE & ADMINISTRATION SECTION

Directions:

Use as directed.

Clean the affected area before application.

Apply a thin layer to the affected area, 2-3 times daily or as directed by a physician.

WARNINGS SECTION

Warnings:

For external use only.

Avoid contact with eyes and mucous membranes.

Keep out of reach of children.

If you have severe symptoms, consult a doctor before use.

Do not use on deep and puncture wounds, severe burns, and infected skin.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings:

Keep out of reach of children.

STORAGE AND HANDLING SECTION

Storage:

Store in a cool, dry place below 30°C (86°F).

Protect from direct sunlight.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package 1: jar label

CalendulaCalendula

Package 2: Tube

bottle designs calendulabottle designs calendula

Carton Box

calendula ointment Boxcalendula ointment Box

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeQR CodeBM Homoeopathic Pharmaceuticals Calendula (Ointment) 40gm Help support to relieve the symptoms of skin ailments (For external use only) DRAP Mfg. Enl. # 0041, Prod. Enl. # 0041880981Calendula.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85816-6021-1BM Calendula40 g in 1 JAROINTMENT406
85816-6021-2BM Calendula40 g in 1 TUBEOINTMENT406

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
85816-602185816-6021-1, 85816-6021-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
JASMINUM OFFICINALE FLOWER0Q8K841432IACT
ALOE VERA LEAFZY81Z83H0XACTIB
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CHAMOMILEFGL3685T2XACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MINERAL OILT5L8T28FGPIACT
WHITE PETROLATUMB6E5W8RQJ4IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-12-03monthly-update2026-06-03 17:44:52
22025-10-15monthly-update2026-06-03 17:37:50
12025-06-27full-release2026-06-01 02:34:11

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
BM CalendulaCALENDULA OFFICINALISBM Private Limited388ca53f-be13-b8d1-e063-6294a90a12342026-02-12WarningsExact identifier
ndc (package): 85816-6021-2
ndc (package): 85816-6021-1
ndc (product): 85816-6021
ndc11 (package): 85816602102
ndc11 (package): 85816602101
spl id: 4aa04213-1782-0c54-e063-6394a90a6ba1
spl set id: 388ca53f-be13-b8d1-e063-6294a90a1234

Reported adverse events (FAERS/openFDA)#

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