MYOMEGA  OMEGA 3PLUS TARGETED RELIEF- menthol and camphor (synthetic) spray 
Concept Laboratories, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MYOMEGA®
OMEGA
3+
Targeted
Relief
Spray

Drug Facts

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

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

When using this product do not get into eyes

  • avoid contact with other mucous membranes

Extremely 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 sprayer's yellow locking mechanism counter-clockwise to unlock; clockwise to lock. Lock sprayer when not in use.
  • Children under 12 years of age consult a physician
  • Sprayer will need to be primed before initial use. Squeeze trigger pointed away from face several times until liquid dispenses. Sprayer can dispense at a 180° angle, but will need to be re-primed periodically
  • Spray liberally to affected area not more than 3 to 4 times daily
  • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Inactive ingredients

SD Alcohol 40-B, Water (Aqua), Aloe Barbadensis Leaf Juice, Acrylates Copolymer, Polysorbate 20, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Linum Usitatissmum (Linseed) Seed Oil, Euterpe Oleracea Fruit 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.

Questions or comments?

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

Concept Laboratories, Inc.
Chicago, IL 60642 (USA)

PRINCIPAL DISPLAY PANEL 118 mL Bottle Label

MYOMEGA®

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

OMEGA™
3+

Targeted
Relief
Spray
for hard to
reach areas

with:

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

4 FL OZ (118 mL)

NDC 64058-142-64

Principal Display Panel
MYOMEGA   OMEGA 3PLUS TARGETED RELIEF
menthol and camphor (synthetic) spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-142
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form14.16 g  in 118 mL
Camphor (Synthetic) (UNII: 5TJD82A1ET) (Camphor (Synthetic) - UNII:5TJD82A1ET) Camphor (Synthetic)7.08 g  in 118 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
LAURYL LAURATE (UNII: GPW77G0937)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALCOHOL (UNII: 3K9958V90M)  
LINSEED OIL (UNII: 84XB4DV00W)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
ACAI OIL (UNII: Z0W6766A2W)  
STARCH, CORN (UNII: O8232NY3SJ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-142-64118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/03/200903/28/2015
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/03/200903/28/2015
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-142)

Revised: 3/2017
 
Concept Laboratories, Inc.