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#
Contacts and useful links#
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 - QUESTIONS SECTION
Questions, Comments?
www.BoironCalendula.com
www.BoironUSA.com
1-800-BOIRON-1
(1-800-264-7661)
Distributed by Boiron Inc.
6 Campus Boulevard
Newtown Square, PA
19073-3267
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
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0220-1109-68 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-7e10-f424-e053-dadaa90a57ce | Calendula Cream 0.5oz |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0220-1109-63 | GM - Gram | 0220-1109 | 5d8b143b-02aa-47ac-b354-e5ae259cbad7 | 1 | 2021-02-05 |
Products#
Every source-derived product name is available through these pages.
- CALENDULA
- CAPRYLYL GLYCOL
- CARBOMER 934
- CETYL PALMITATE
- EDETATE DISODIUM
- WATER
- SODIUM HYDROXIDE
- SORBIC ACID
- 1,2-HEXANEDIOL
- GLYCERIN
- LAUROYL PEG-32 GLYCERIDES
- PEGOXOL 7 STEARATE
- ALCOHOL
- CALENDULA OFFICINALIS FLOWERING TOP
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0220-1109 | 0220-1109-68 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| CAPRYLYL GLYCOL | 00YIU5438U | IACT |
| CARBOMER 934 | Z135WT9208 | IACT |
| CETYL PALMITATE | 5ZA2S6B08X | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| SORBIC ACID | X045WJ989B | IACT |
| 1,2-HEXANEDIOL | TR046Y3K1G | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LAUROYL PEG-32 GLYCERIDES | H5ZC52369M | IACT |
| PEGOXOL 7 STEARATE | 3EW5AXE5X5 | IACT |
| ALCOHOL | 3K9958V90M | IACT |
| CALENDULA OFFICINALIS FLOWERING TOP | 18E7415PXQ | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Calendula | CALENDULA OFFICINALIS FLOWERING TOP | Laboratoires Boiron | 2ed51803-5ec2-4163-ad12-2bf441551f07 | 2025-12-09 | Warnings | 0220-1109-68 0220-1109 00220110968 |
| 6995382d-44c8-1e14-e053-2a91aa0a0cd7 | 28c76b61-2a0a-0f52-e054-00144ff8d46c | 2018-04-11 | Warnings | 6995382d-44c8-1e14-e053-2a91aa0a0cd7 28c76b61-2a0a-0f52-e054-00144ff8d46c |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.



