Label: TOTAL MUSCLE RELIEF- menthol, camphor spray

  • 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 16, 2019

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  • Active Ingredient

    Menthol ---10.5%

  • Purpose

    Cooling Pain Relief

  • USES

    Temporary relief from minor aches and pains of sore muscles and joints associated with arthrilis backaches strains and sprains

  • WARNINGS

    For external use only.
    Flammable; Keep away from excessive heat or open-flame.
    Ask doctor before use if you have: Sensitive skin.
    When using this product: Avoid contact with the eyes or mucus membranes. Do not apply to wounds or damaged skin. Do not use with other ointments, creams, sprays or liniments. Do not apply to irritated skin of if excessive irritation develops. Do not bandage. Wash hand after use with cold water. Do not use heating pads or device. Store in a cool dry place. Stop use and ask doctor if: condition worsens or if symptoms persist for more than 7 days or clear up and recur.
    If pregnant or breast feeding: ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children: if accidently ingested get medical help or contact Poison Control Center immediately

  • DIRECTIONS

    Adult and children 12 years of age and older: Spray on to the affected areas not more than four times daily. Massage not necessary.
    Children under 12 years of age: Consult physician.

  • Inactive ingredients

    Purified water, Extract of Aloe Vera, Witch Hazel, Water Cress and Rosemary, Isopropanol, Glycerin, Polysorbate 20, Coconut Oil, Sweet Almond Oil, Emu Oil

  • PRINCIPAL DISPLAY PANEL

    TOTAL MUSCLE RELIEF 4oz spray v1.1

  • INGREDIENTS AND APPEARANCE
    TOTAL MUSCLE RELIEF 
    menthol, camphor spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50130-109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    WATERCRESS (UNII: K5877MW0LE)  
    ROSEMARY (UNII: IJ67X351P9)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    EMU OIL (UNII: 344821WD61)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50130-109-14118 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/16/2019
    Labeler - Electrostim Medical Services Inc. d/b/a EMSI (932471881)
    Establishment
    NameAddressID/FEIBusiness Operations
    DIVERSIFIED MANUFACTURING CORP185073996manufacture(50130-109)
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