MY OMEGA 3 RUB (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]

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  • MY OMEGA 3 RUB (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]

MY OMEGA 3 RUB (MENTHOL, UNSPECIFIED FORM AND CAMPHOR (SYNTHETIC)) CREAM [CONCEPT LABORATORIES, INC.]
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NDC 64058-345-68
Set ID 59981474-c827-40c9-be3c-62a38cb575ca
Category HUMAN OTC DRUG LABEL
Packager Concept Laboratories, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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

    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), 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

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 237 ml Bottle Label

    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
  • INGREDIENTS AND APPEARANCE
    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)
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