Label: MUSCLE AND JOINT HEAT CREAM- eucalyptus oil and tea tree oil cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated April 8, 2016

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  • Actives

    Tea Tree Oil (Melaleuca Alternifolia) - 42.5 mg/g
    Eucalyptus Oil (Eucalyptus radiata ) - 38.6 mg/g

    Winter Green  Oil (Methyl Salicylate)- 50 mg/g

  • Purpose

    Pain relief cream to assist with relief of joint and muscle pain

  • INACTIVE INGREDIENT

  • Indication and Usage

    For the temporary relief of muscle andjoint aches and pains, includingsymptomatic relief of lower back pains.

    May also assist with increased jointmobility & reduce inflammation andswelling of affected areas.

    Contains phenoxyethanol as a preservative.

  • Dosage and Administration

    Apply a small amount of Muscle and Joint Heat Cream to the affected area and massage in until fully absorbed. Use twice

    daily or more frequently if required.

  • Warnings

    For external use only.

    Ensure safety seal is intact beforeopening. Keep tube sealed when not being used. Store below 300 C (86 F).

    Keep out of reach from Children

  • KEEP OUT OF REACH OF CHILDREN

  • Product Carton Label

    heat-cream

  • INGREDIENTS AND APPEARANCE
    MUSCLE AND JOINT HEAT CREAM 
    eucalyptus oil and tea tree oil cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69594-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662) EUCALYPTUS OIL38.6 mg  in 1 g
    TEA TREE OIL (UNII: VIF565UC2G) (TEA TREE OIL - UNII:VIF565UC2G) TEA TREE OIL42.5 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69594-003-01100 g in 1 TUBE; Type 0: Not a Combination Product02/16/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/16/2015
    Labeler - Ultra Mix (Aust) Pty Ltd (752254649)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Mix (Aust) Pty Ltd752254649manufacture(69594-003)
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