Label: MUELLERGESIC (menthol 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 8, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Menthol 12%Pain Relief
    Camphor 6%Pain Relief
  • 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
    • do not use with heating pad, pack, wrap, hot water bottle or any heating element.

    When using this product do not get into eyes

    • avoid contact with other mucous membranes

    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 a thin layer 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), 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 1-800-356-9522 or Email us at sportcare@muellersportsmed.com

  • SPL UNCLASSIFIED SECTION

    Extremely Flammable:
    Keep from heat and flame

  • PRINCIPAL DISPLAY PANEL - 106 g Bottle Label

    MUELLER®

    Muellergesic®
    Cream
    topical analgesic

    Cooling Menthol &
    Camphor     relieves
    muscle and joint pain

    HELPS TO RELIEVE PAIN
    ASSOCIATED WITH

    • Strains
    • Sprains
    • Muscle Aches & Pain
    • Arthritis
    • Joint Pain

    Timed-Release
    IcePearls™

    6h

    NET WT 3.75 OZ (106 g)

    31200 LBL31200A - 9.16

    PRINCIPAL DISPLAY PANEL - 106 g Bottle Label
  • INGREDIENTS AND APPEARANCE
    MUELLERGESIC 
    menthol and camphor (synthetic) cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52564-312
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol (UNII: L7T10EIP3A) (Menthol - UNII:L7T10EIP3A) Menthol12.72 g  in 106 g
    Camphor (synthetic) (UNII: 5TJD82A1ET) (Camphor (synthetic) - UNII:5TJD82A1ET) Camphor (synthetic)6.3 g  in 106 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    ACAI OIL (UNII: Z0W6766A2W)  
    PPG-2 HYDROXYETHYL COCAMIDE (UNII: 34N07GUJ3X)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    LAURYL LAURATE (UNII: GPW77G0937)  
    METHYL DIISOPROPYL PROPIONAMIDE (UNII: 6QOP5A9489)  
    ETHYL MENTHANE CARBOXAMIDE, 1R,3R,4S (UNII: 3NJ8V2450N)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52564-312-02106 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2016
    2NDC:52564-312-01106 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/25/201403/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34806/25/2014
    Labeler - Mueller Sports Medicine LLC (006426316)
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