Calendula Gel

Manufacturer
Sled Distribution, LLC
Effective date
2022-04-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:17:18

Label at a glance#

ProductMy Medic Calendula Gel
Active ingredientCALENDULA OFFICINALIS FLOWER
Label structure9 sections

Indications and uses

temporarily relieve muscle pain and stiffness due to:  minor infuries overexertion  falls reduces symptoms of bruising such as discoloration, pain, and swelling.

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

Purpose Section

OTC - PURPOSE SECTION

Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Calendula Officinalis Flower Extract ...... 4%

Indications and Usage

INDICATIONS & USAGE SECTION

temporarily relieve muscle pain and stiffness due to: 

  • minor infuries
  • overexertion 
  • falls
  • reduces symptoms of bruising such as discoloration, pain, and swelling.

Keep our of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Poison Control Center right away.

Warning Section

WARNINGS SECTION

Warnings

For external use only.

■ Do not use on if are allergic to Calendula or any of this product's inactive ingredients.

When using this product

■ avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin.

■dryness or irritation may occur

  • Use on as directed
  • do not tightly wrap or bandage the treated area
  • do not apply heat or ice to the treated area immediately before or after use.

Stop use and ask a doctor if

  • conditions persist for more than 3 days or worsens
  • symptons clear up and occur again within a few days.

Storange and Handling

STORAGE AND HANDLING SECTION

Store at room temperature.

Dosage & Administration

DOSAGE & ADMINISTRATION SECTION

apply a thin layer of gel toaffected area as soon as possible after minor injure. Repeat 3 time a day or as needed. If heat or ice is applied, wait 5 minutes before applying ointment.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

White Petroleum, Water

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codel.ead.me/bcrLAnCalendula Gel.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81417-126-012023-07-28C16284748780-10191ceaa-647c-198a-e063-dbdaa90aec3eCalendula Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81417-126-01My MedicCalendula Gel3.5 g in 1 PACKAGEGEL3.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81417-126MY MEDIC CALENDULA GEL (CALENDULA OFFICINALIS FLOWERS) GEL [SLED DISTRIBUTION, LLC]1Legacy NDC, 1 package rows20220407_38823385-1929-4a44-8dba-7872f6a8bfd8.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81417-12681417-126-01

Ingredients#

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

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
be234fe2-9047-433f-9fed-09a5e9c1ca3538823385-1929-4a44-8dba-7872f6a8bfd82022-04-07WarningsExact identifier
spl id: be234fe2-9047-433f-9fed-09a5e9c1ca35
spl set id: 38823385-1929-4a44-8dba-7872f6a8bfd8

Reported adverse events (FAERS/openFDA)#

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