Australian Approved Name (AAN): Sodium perborate
Common names and synonyms: Sodium perborate trihydrate
Organic/Inorganic: Inorganic
Molecular formula: NaBO3.4H2O
Molecular Weight: 153.86
Conversions (% Boron): 7.02 (% sodium): 14.94
Maximum daily dose: 6mg Boron (when for internal use)
Mandatory component: Boron
Warnings and Restrictions: When used in preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron from all ingredients in the product must not exceed 3500 mg/kg or 3500 mg/L or 0.35%.
The requirements specified in paragraphs (a) to (d) below apply to a medicine that contains the ingredient:
(a) When the maximum recommended daily dose of the medicine provides more than 3 mg of boron and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label:
NTAKEN12 – Not to be taken by children under 12 years old (or words to that effect); or
ADULT – Adults only (or words to that effect).
(b) When the maximum recommended daily dose of the medicine provides more than 1 mg boron and up to, and including, 3 mg of boron, and the medicine is for internal use and/or oral application, one of the following warning statements is required on the label:
NTAKEN2 – Not to be taken by children under 2 years old (or words to that effect); or
ADULT – Adults only (or words to that effect).
(c) When for excipient use and the maximum recommended daily dose of the medicine provides more than 1 mg of boron and the medicine is for internal use and/or oral application, the following warning statement is required on the label:
BORON – Contains boron (or words to that effect).
(d) When the medicine is for topical use for dermal application, the following warning statement is required on the label:
BROKEN – Use on unbroken skin only (or words to that effect).
Allowable purpose of the ingredient: Active. Homeopathic
TGA reference: British Pharmacopoeia