FDA.reportPublic FDA data

My Omega 3

Manufacturer
Concept Laboratories, Inc.
Effective date
2016-09-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:13

Label at a glance#

ProductMy Omega 3 Rub
Active ingredientMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)
Label structure9 sections

Indications and uses

for the temporary relief of minor aches and pains of muscles and joints associated with simple backache arthritis strains sprains

Dosage and administration

Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock Children under 12 years of age consult a physician Apply liberally to affected area not more than 3 to 4 times daily Gently massage into the skin until fully absorbed Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Menthol 12%Pain Relieving
Camphor 6%Pain Relieving

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

  • do not apply to wounds or damaged skin
  • do not bandage tightly

OTC - WHEN USING SECTION

When using this product do not get into eyes

  • avoid contact with other mucous membranes

Flammable

SPL UNCLASSIFIED SECTION

Keep from heat and flame.

OTC - STOP USE SECTION

Discontinue use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • if pregnant or nursing, seek the advice of a health professional before using

Directions

DOSAGE & ADMINISTRATION SECTION

  • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock
  • Children under 12 years of age consult a physician
  • Apply liberally to affected area not more than 3 to 4 times daily
  • Gently massage into the skin until fully absorbed
  • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Copolymer, Corn Starch Modified, Linum Usitatissimum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Hydrolyzed Corn Starch, Lauryl Laurate, Methyl Diisopropyl Propionamide, Ethyl Menthane Carboxamide, Menthyl Lactate, Hydrated Silica, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch Octenylsuccinate.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-888-373-8831 or visit us at www.myomegapain.com

SPL UNCLASSIFIED SECTION

Manufactured by:
Concept Laboratories, Inc.
Chicago, IL 60642

PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MYOMEGA®

OMEGA™
3+

Triple Strength
Pain
Relief
Rub

with:

  • Menthol &
    Camphor
  • Anti-Inflammatory
    Omegas 3, 6 & 9
  • Açai Extract
  • and Timed-Release

IcePearls ™

8 FL OZ (237 ml)

Paraben-free topical analgesic for:
Strains • Sprains • Muscle Pain • Tension

PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1150970camphor 6 % / menthol 12 % Topical CreamPSN1
1150970camphor 60 MG/ML / menthol 120 MG/ML Topical CreamSCD1
1150970camphor 6 % / menthol 12 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64058-345-682020-01-31C16284748780-19d75b9d0-c5ad-f424-e053-dadaa90a57ceMy Omega ® 3 Rub

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64058-345-68My Omega 3 Rub234 g in 1 BOTTLECREAM2341

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64058-345MY OMEGA 3 RUB (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]1Legacy NDC, 1 package rows20160923_59981474-c827-40c9-be3c-62a38cb575ca.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64058-34564058-345-68

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
Water059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEPPERMINT OILAV092KU4JHIACT
ALCOHOL3K9958V90MIACT
STARCH, CORNO8232NY3SJIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
LINSEED OIL84XB4DV00WIACT
ROSEMARY OIL8LGU7VM393IACT
ACAI OILZ0W6766A2WIACT
PPG-2 HYDROXYETHYL COCAMIDE34N07GUJ3XIACT
METHYL DIISOPROPYL PROPIONAMIDE6QOP5A9489IACT
ETHYL MENTHANE CARBOXAMIDE6S7S02945HIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
LAURYL LAURATEGPW77G0937IACT
HYDRATED SILICAY6O7T4G8P9IACT

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
fc963a5a-6c62-43e6-8b38-e60d90727d3359981474-c827-40c9-be3c-62a38cb575ca2016-09-13WarningsExact identifier
spl id: fc963a5a-6c62-43e6-8b38-e60d90727d33
spl set id: 59981474-c827-40c9-be3c-62a38cb575ca

Reported adverse events (FAERS/openFDA)#

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