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My Omega

Concept Laboratories, Inc.

My Omega Heat Therapy


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredient Purpose
Capsicum Oleoresin 0.0625% Pain
(Containing Capsaicin 0.025%) Relieving

My Omega Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

For external use only.

  • do not apply to wounds or damaged skin
  • do not bandage tightly
  • do not use with heating pad, pack, wrap, hot water bottle or any heating element

When using this product do not get into eyes

  • avoid contact with other mucous membranes

Flammable

Keep from heat and flame.

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

Keep out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away
  • if pregnant or nursing, seek the advice of a health professional before using

Directions

  • 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

Water (Aqua), SD Alcohol 40-B, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Acrylates Copolymer, Linum Usitatissmum (Linseed) Seed Oil, Euterpe Oleracea Friuit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Methane Carboximide, Methyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate, Acrylates/C 10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate.

Questions or comments?

Call 1-888-373-8831

PRINCIPAL DISPLAY PANEL - 106 g Bottle Label

MY O MEGA ®

NDC 64058-146-34

OMEGA
3+

Penetrating
Heat
Therapy
Cream

with:

  • Capsaicin
  • Anti-Inflammatory
    Omegas 3, 6 & 9
  • Açai Extract
  • and Timed-Release
    IcePearls

NET WT 3.75 OZ. (106 g)

My Omega

My Omega

Capsaicin CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64058-146
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
capsaicin CAPSAICIN 0.0265 g

Inactive Ingredients

Ingredient Name Strength
water
ARNICA MONTANA FLOWER
METHYL DIISOPROPYL PROPIONAMIDE
LAURYL LAURATE
PHENOXYETHANOL
DMDM HYDANTOIN
IODOPROPYNYL BUTYLCARBAMATE
Aloe Vera Leaf
METHYL LACTATE, L-
STARCH, CORN
PPG-2 HYDROXYETHYL COCAMIDE
TROLAMINE
ALCOHOL
PEPPERMINT OIL
LINSEED OIL
ACAI OIL
ROSEMARY OIL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64058-146-34 106 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2009-02-18


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