Original Pain Relief Cream

ORIGINAL PAIN RELIEF CREAM- eucalyptus oil and tea tree oil cream
Ultra Mix (Aust) Pty Ltd

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.

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

ORIGINAL PAIN RELIEF CREAM eucalyptus oil and tea tree oil cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69594-004 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL 38.6 mg in 1 g TEA TREE OIL (TEA TREE OIL) TEA TREE OIL 42.5 mg in 1 g

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:69594-004-01 100 g in 1 TUBE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 02/16/2015

Labeler — Ultra Mix (Aust) Pty Ltd (752254649)

Establishment
Name	Address	ID/FEI	Operations
Ultra Mix (Aust) Pty Ltd		752254649	manufacture (69594-004)

Revised: 02/2015 Ultra Mix (Aust) Pty Ltd