MY OMEGA 3  RUB- menthol, unspecified form and camphor (synthetic) cream 
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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My Omega® 3
Rub

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

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

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

Inactive ingredients

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?

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

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

PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label

MYOMEGA®

OMEGA
3+

Triple Strength
Pain
Relief
Rub

with:

IcePearls

8 FL OZ (237 ml)

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

PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label
MY OMEGA 3   RUB
menthol, unspecified form and camphor (synthetic) cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-345
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM0.12 g  in 1 g
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
ALCOHOL (UNII: 3K9958V90M)  
STARCH, CORN (UNII: O8232NY3SJ)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
LINSEED OIL (UNII: 84XB4DV00W)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
ACAI OIL (UNII: Z0W6766A2W)  
PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
ETHYL MENTHANE CARBOXAMIDE (UNII: 6S7S02945H)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
LAURYL LAURATE (UNII: GPW77G0937)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64058-345-68234 g in 1 BOTTLE; Type 0: Not a Combination Product06/27/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34806/27/2016
Labeler - Concept Laboratories, Inc. (962282612)
Establishment
NameAddressID/FEIBusiness Operations
Concept Laboratories, Inc.962282612MANUFACTURE(64058-345)

Revised: 9/2016
Document Id: fc963a5a-6c62-43e6-8b38-e60d90727d33
Set id: 59981474-c827-40c9-be3c-62a38cb575ca
Version: 1
Effective Time: 20160913
 
Concept Laboratories, Inc.