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Omega Pain Relieving (International Pharmaceuticals, Inc.)

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LINIMENT 1 BOTTLE in 1 CARTON (58929-200-00) > 120 mL in 1 BOTTLE Label Information

Complete Omega Pain Relieving Information

  • ACTIVE INGREDIENT

    Active Ingredients                                                               Purpose

    Camphor 4.0 percent

                                               ............................................Topical Analgesic

    Menthol 3.33 percent

    Methyl Salicylate 14.775 percent .....................................Counterirritant


  • PURPOSE

    Uses

    For the temporary relief of minor aches and pains of muscle and joints associated with:

    Simple Backache

    Arthritis

    Strains



  • WARNINGS

    Warnings

    For external use only.           Avoid Contact with eyes.

    If condition worsens, or if symptoms persist for more than

    7 days or clear up and occur again within a few days,

    discontinue use of this product and consult a doctor.

    When used for arthritis, if pain persists for more than 10 days,

    or redness is present, or in conditions affecting children under

    12 years of age, consult a physician immediately.


  • DO NOT USE

    Do Not

    use otherwise than as directed.

    apply to wounds or damaged skin.

    bandage tightly.



  • ASK DOCTOR

    Stop use and ask a doctor if

    redness is present.

    excessive irritation of the skin develops.



  • KEEP OUT OF REACH OF CHILDREN


    Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control Center right away.


  • DOSAGE & ADMINISTRATION

    Directions

    Shake well before using.

    Adults and children 3 years of age and older: Apply to affected area not more than 3 to 4 times daily.

    Children under 3 years of age: Consult a physician.



  • STORAGE AND HANDLING

    Other information

    Store at 20 to 30 celsius  (68 to 86 Fahrenheit)


  • INACTIVE INGREDIENT


    Inactive Ingredients

    Carboxymethylcellulose Sodium,
    D and C Green number 6, D and C Yellow number 11, Eucalyptus Oil, Light Mineral Oil, Magnesium, Aluminum Silicate,
    Methylparaben, Oleic Acid, Propylparaben, Purified Water, Sodium Octoxynol-2 Ethane Sulfonate, Sorbitol Solution, Triethanolamine,
    Turpentine Oil.

  • PRINCIPAL DISPLAY PANEL

    Omega Pain Relieving Liniment

    For external use only.

    Net 4 fl oz (120 ml)

    For your protection, this bottle is provided with a pilfer proof cap imprinted with the IPI

    logo in red. Do not use if cap has been tampered with or is broken or destroyed.



  • DESCRIPTION

    Manufactured By

    International Pharmaceuticals, Inc.

    Juan Luna Avenue, Mabolo,

    Cebu City 6000 Philippines

    Product Of The Philippines

    Shake well before using

    www.ipi-phil.com



  • INGREDIENTS AND APPEARANCE
    OMEGA PAIN RELIEVING 
    camphor, menthol, methyl salicylate liniment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58929-200
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC) 4 mL  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 3.33   in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 14.775 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    D&C GREEN NO. 6 (UNII: 4QP5U84YF7)  
    D&C YELLOW NO. 11 (UNII: 44F3HYL954)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MAGNESIUM (UNII: I38ZP9992A)  
    ALUMINUM SILICATE (UNII: T1FAD4SS2M)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    TURPENTINE (UNII: XJ6RUH0O4G)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58929-200-00 1 in 1 CARTON
    1 120 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part348 05/24/2010
    Labeler - International Pharmaceuticals, Inc. (718692460)
    Registrant - International Pharmaceuticals, Inc. (718692460)
    Establishment
    Name Address ID/FEI Business Operations
    International Pharmaceuticals, Inc. 718692460 manufacture