Label: BIOMEGA COLD PAIN THERAPY (menthol, unspecified form and camphor- synthetic cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated February 3, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Menthol 12% Topical Analgesic
    Camphor 6%Topical Analgesic
  • 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.

    • This is not a face cream. Do not apply to the face.
    • If sensitive skin, ask a health professional before use. Do not use if past allergic reaction to menthol or camphor.
    • Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin.
    • Do not bandage tightly.
    • Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product, burning sensation or cold sensation.
    • Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.

    When using this product

    • Do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.

    Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling, skin irritation or blistering of the skin.

    If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.

    Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. Get emergency medical help if difficulty breathing, swelling of face, lips, tongue or throat, or hives.

  • Directions

    • Rotate pump's spout counter-clockwise slightly to unlock; clockwise to lock.
    • Before using on children under 18 years of age consult a physician.
    • Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small skin area to test for sensitivity or skin reaction.
    • Gently massage into the skin until fully absorbed.
    • Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.
  • WARNING

    FLAMMABLE PRODUCT!

    Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

  • Inactive ingredients

    Water (Aqua), SD Alcohol 40-B, Aloe Barbadensis Leaf Juice, 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 1-877-630-9788 or visit us at www.biomegarxp.com

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

    BIOMEGA™

    Triple Strength

    COLD PAIN THERAPY Cream

    with Cooling Menthol &
    Camphor

    • Omegas 3,6 & 9
    • With Natural Ingredients
    • Ice Pearls™ Technology
      For Hours Of Therapy

    8 FL OZ (237mL)

    Principal Display Panel - 237 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    BIOMEGA   COLD PAIN THERAPY
    menthol, unspecified form and camphor (synthetic) cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64058-344
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64058-344-68234 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34801/07/2016
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    NameAddressID/FEIBusiness Operations
    Concept Laboratories, Inc.962282612MANUFACTURE(64058-344)
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