Document ID: chunk:federal_register_of_legislation:F2025L00049:clause:10_1
Version: federal_register_of_legislation:F2025L00049
Segment Type: clause
Provision Reference: sch 10 cl 1
Character Range: 843116–844779

1  General
 (1) This clause sets out requirements for the purposes of paragraph 40(b).
 (2) All details, words and other required information on a label on a container of a substance for therapeutic use must be in the English language in letters at least 1.5 mm in height.
 (3) All symbols, numbers and words on a label must be in durable characters.
 (4) The label on a container of a substance for therapeutic use must contain the following details:
 (a) the name, address and telephone number of the dispenser supplying the substance;
 (b) the approved name of the substance and/or its proprietary name (unless it is a preparation compounded in accordance with the dispenser's own formula);
 (c) adequate directions for use;
 (d) the strength and form of the substance;
 (e) the total quantity of the goods in the container;
 (f) the words "KEEP OUT OF REACH OF CHILDREN" in red on a white background;
 (g) if the substance is intended for external use only, the word "POISON", or the words "FOR EXTERNAL USE ONLY", in red on a white background;
 (h) if the substance is a medicine for human use, the name of the person for whom it was dispensed; and
 (i) if the substance is a veterinary chemical, the species of animal, the name of the animal's owner and the words "FOR ANIMAL TREATMENT ONLY".
 (5) The label on a container of a medicine for human use, or a veterinary chemical, that is supplied on prescription must also include:
 (a) the prescription reference number; and
 (b) the date on which the prescription was supplied (unless that date is clear from the prescription reference number); and
 (c) the directions for use set out in the prescription.