MUSCLE AND JOINT HEAT CREAM (EUCALYPTUS OIL AND TEA TREE OIL) CREAM [ULTRA MIX (AUST) PTY LTD ]

MUSCLE AND JOINT HEAT CREAM (EUCALYPTUS OIL AND TEA TREE OIL) CREAM [ULTRA MIX (AUST) PTY LTD ]
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NDC 69594-003-01
Set ID 0a452a0b-6dea-4a03-b7ea-fec440f83c29
Category HUMAN OTC DRUG LABEL
Packager Ultra Mix (Aust) Pty Ltd
Generic Name
Product Class
Product Number
Application Number
  • 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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