Label: KYMARO ROLL ON RELIEF- menthol and camphor (synthetic) cream

  • NDC Code(s): 64058-541-13
  • Packager: Concept Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 11/13

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients Purpose
    Menthol 12% Topical Analgesic
    Camphor 6% Topical Analgesic
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  • Uses

    for the temporary relief of minor aches and pains of muscles and joints associated with

    • simple backache
    • arthritis
    • strains
    • sprains
    • bruises
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  • Warnings

    For external use only.

    • Flammable: Keep from heat and flame. Use only as directed.
    • do not apply to wounds or damaged skin
    • do not bandage tightly
    • do not use with heating pad, wrap, hot water bottle or any heating element.

    When using this product do not get into eyes

    • avoid contact with other mucous membranes
    • if eye contact occurs, flush immediately with water

    Stop 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 care professional before using
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  • Directions

    • for adults and children 18 years of age and older
    • apply liberally to affected area up to 4 times daily, unless otherwise directed by a physician
    • allow to fully absorb into skin
    • if necessary, wash hands with soap and water after application
    • if applying to hands, wait 30 minutes before washing
    • avoid contact with eyes, mucous membranes, damaged or irritated skin
    • insert contact lenses prior to application
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  • Inactive ingredients

    Water (Aqua), Aloe Barbadensis Leaf Juice, SD Alcohol 40-B, Propylene Glycol, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Carbomer, Acrylates Coploymer, Corn Starch Modified, 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, Phenoxyethanol, DMDM Hydantoin, Iodopropynyl Butylcarbamate

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  • PRINCIPAL DISPLAY PANEL - 85g Bottle Label

    KYMARO®
    HEALTH & BEAUTY / SPA ESSENTIALS

    NEW!

    Roll-On
    RELIEF
    Cream

    No Mess
    APPLICATOR

    PENETRATING
    PAIN RELIEF

    EFFECTIVE STRENGTH

    PAIN RELIEVING CREAM

    NET WT 3 OZ (85g)

    Principal Display Panel - 85g Bottle Label
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  • INGREDIENTS AND APPEARANCE
    KYMARO   ROLL ON RELIEF
    menthol and camphor (synthetic) cream
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:64058-541
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL 10.2 g  in 85 g
    CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 5.1 g  in 85 g
    Inactive Ingredients
    Ingredient Name Strength
    Water  
    ALOE VERA LEAF  
    PROPYLENE GLYCOL  
    PEPPERMINT OIL  
    ALCOHOL  
    STARCH, CORN  
    ARNICA MONTANA FLOWER  
    LINSEED OIL  
    ROSEMARY OIL  
    ACAI OIL  
    PPG-2 HYDROXYETHYL COCAMIDE  
    METHYL DIISOPROPYL PROPIONAMIDE  
    METHYL LACTATE, L-  
    LAURYL LAURATE  
    DMDM HYDANTOIN  
    PHENOXYETHANOL  
    IODOPROPYNYL BUTYLCARBAMATE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64058-541-13 85 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 09/24/2012
    Labeler - Concept Laboratories, Inc. (962282612)
    Establishment
    Name Address ID/FEI Business Operations
    Concept Laboratories, Inc. 962282612 MANUFACTURE(64058-541)
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