Borax 1269 views0 applications

Australian Approved Name (AAN): Borax

Common names and synonyms: Borax decahydrate; Sodium borate, Sodium tetraborate

Organic/Inorganic: Inorganic

Molecular formula: Na2B4O7.10H2O

Molecular weight: 381.4

Conversions (% Boron): 11.34

Maximum daily dose: The maximum recommended daily dose must provide no more than 6mg of Boron.

Warnings and restrictions: Boron is a mandatory component of borax.

The percentage of boron from borax should be calculated based on the molecular weight of borax.

The maximum recommended daily dose must not provide more than 6mg of boron.

In preparations for dermal use, which are not for paediatric or antifungal use, the concentration of boron in the medicine must be no more than 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. Excipient. Homeopathic

TGA reference: British Pharmacopoeia

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