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 used in a medicine:
(a) with an oral route of administration;
(b) not indicated for laxative (or related) use; and
(c) where the maximum recommended daily dose for:
(i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;
(ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or
(iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts; the following warning statement is required on the medicine label:
LAX6 – Contains magnesium, which may have a laxative effect or cause diarrhoea (or words to that effect).
When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.
Allowable purpose of the ingredient: Active. Excipient. Homeopathic.
TGA Reference: International Cosmetic Ingredient Directory