Label: ORIGINAL PAIN RELIEF CREAM- eucalyptus oil and tea tree oil cream

  • Category: HUMAN PRESCRIPTION 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 February 16, 2015

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

  • Actives

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

  • Purpose

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

  • Indication and Usage

    For the temporary relief of arthritic pain & relief of muscular aches & pains, including symptomatic relief of lower back pains. May

    also assist with increased joint mobility & reduce inflammation and swelling associated with arthritis and gout.

  • Dosage and Administration

    Apply a small amount of  Original Pain Relief Cream to the affected area & gently 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).

    If symptoms persist seek the advice of a health care practioner.

    Keep out of reach from children.

  • Product Carton Label

    pain-relief

  • INGREDIENTS AND APPEARANCE
    ORIGINAL PAIN RELIEF CREAM 
    eucalyptus oil and tea tree oil cream
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69594-004
    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
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69594-004-01100 g in 1 TUBE
    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(69594-004)