Calendula Cream 0.5oz

Manufacturer
Boiron | Boiron Inc.
Effective date
2018-04-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:00:07

Label at a glance#

ProductCALENDULA
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure14 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Calendula Officinalis 1X HPUS

INDICATIONS & USAGE SECTION

  • Helps promote healing of cuts, scrapes, chafing, minor burns and sunburn.

OTC - DO NOT USE SECTION

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

  • Do not use if the tube seal is broken.

DOSAGE & ADMINISTRATION SECTION

For minor burns, immediately run cool water on the burn for several minutes and dry. For cuts, scrapes, and chafing, first cleanse the area with mild soap, rinse and dry.

  • Then apply a thin layer of Calendula Cream to affected area 3 times a day or as needed.

INACTIVE INGREDIENT SECTION

Version With Disodium EDTA:

Alcohol, Caprylyl glycol, carbomer, cetyl palmitate, EDTA disodium, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol


Version without Disodium EDTA:

Alcohol, Caprylyl glycol, carbomer, cetyl palmitate, glycerin, lauroyl macrogolglycerides, pegoxol-7 stearate, purified water, sodium hydroxide, sorbic acid, 1,2-hexanediol

HOW SUPPLIED SECTION

Tube .5 OZ (14 G)

OTC - PURPOSE SECTION

Calendula officinalis 1X ... Healing agent

OTC - ASK DOCTOR SECTION


Ask a doctor before use in case of deep 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

SPL UNCLASSIFIED SECTION

  • Soothes
  • Moisturizes & Heals
  • Paraben-Free

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

boxboxboxboxCalendula Cream boxCalendula Cream box

Calendula Cream tubeCalendula Cream tube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-1109-682020-01-31C16284748780-19d75b9d0-7e10-f424-e053-dadaa90a57ceCalendula Cream 0.5oz

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0220-1109-63GM - Gram0220-11095d8b143b-02aa-47ac-b354-e5ae259cbad712021-02-05

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-11090220-1109-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalendulaCALENDULA OFFICINALIS FLOWERING TOPLaboratoires Boiron2ed51803-5ec2-4163-ad12-2bf441551f072025-12-09WarningsExact identifier
ndc (package): 0220-1109-68
ndc (product): 0220-1109
ndc11 (package): 00220110968
6995382d-44c8-1e14-e053-2a91aa0a0cd728c76b61-2a0a-0f52-e054-00144ff8d46c2018-04-11WarningsExact identifier
spl id: 6995382d-44c8-1e14-e053-2a91aa0a0cd7
spl set id: 28c76b61-2a0a-0f52-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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