81417-007 MY MEDIC CALENDULA GEL

Manufacturer
Sled Distribution, LLC
Effective date
2024-01-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:25:41

Label at a glance#

ProductMY MEDIC CALENDULA
Active ingredientCALENDULA OFFICINALIS FLOWER
Label structure12 sections

Indications and uses

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

Dosage and administration

Apply a thin layer of gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. lf heat or ice is applied, wait 5 minutes before applying ointment.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Calendula Officinalis Flower Extract (4%)

Purpose Section

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

temporarily relieve muscle pain and stiffness due to:

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

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

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

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
  • dryness or irritation may occur
  • use only 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.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • conditions persist for more than3 days or worsens
  • symptoms clear up and occur again within a few days

Keep out 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.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply a thin layer of gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. lf heat or ice is applied, wait 5 minutes before applying ointment.

Other information

OTHER SAFETY INFORMATION

do not use if the sachet seal is broken.

Inactive ingredients

INACTIVE INGREDIENT SECTION

White Petroleum, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of pouch labelimage of pouch label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81417-007-01MY MEDIC CALENDULA3.5 g in 1 POUCHGEL3.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81417-007MY MEDIC CALENDULA (CALENDULA OFFICINALIS FLOWER EXTRACT) GEL [SLED DISTRIBUTION, LLC]2Current NDC, Legacy NDC, 1 package rows20240116_e744741b-c992-3b14-e053-2995a90a61d2.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
81417-00781417-007-01

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
MY MEDIC CALENDULACALENDULA OFFICINALIS FLOWER EXTRACTSled Distribution, LLCe744741b-c992-3b14-e053-2995a90a61d22024-01-15WarningsExact identifier
ndc (package): 81417-007-01
ndc (product): 81417-007
ndc11 (package): 81417000701
spl id: 0f0031aa-78ef-a8ba-e063-6294a90aa7f6
spl set id: e744741b-c992-3b14-e053-2995a90a61d2

Reported adverse events (FAERS/openFDA)#

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