Australian Approved Name (AAN): Bittern
Warnings and Restrictions: Only to be used in a medicine where WA Salt Koolyanobbing Pty Ltd- Australia (Client ID 69736), who applied to have the ingredient included in this Determination, is the sponsor of the medicine or has given written authorisation to the sponsor of a medicine to include the ingredient in the medicine. This paragraph ceases to be a requirement for this ingredient after 8 June 2022.
Magnesium is a mandatory component of bittern.
Only permitted for use in:
– medicines limited to oral routes of administration; and
– topical medicines for dermal administration.
When the medicine is:
(a) used in medicines with an oral route of administration;
(b) not promoted or marketed as laxative; and
(c) the recommended daily dose for:
(i) individuals greater than 9 years of age contains 250 mg or greater magnesium;
(ii) children aged between 4 and 8 years (inclusive) contains 110 mg or greater magnesium; or
(iii) children aged between 1 and 3 years (inclusive) contains 65 mg or greater magnesium; the following warning statements are required on the label:
LAX5 – This product contains magnesium; and
LAX4 – This product may have laxative effect.
When the medicine is for an oral route of administration, the following warning statement is required on the label:
BABY2 – Not suitable for infants under the age of twelve months (or words to that effect).
Allowable purpose of the ingredient: Active. Excipient. Homeopathic.
TGA Reference: International Cosmetic Ingredient Directory