Australian Approved Name (AAN): Citric acid monohydrate
Common names and synonyms: beta-Hydroxytricarballylic acid monohydrate; 2-Hydroxy-1,2,3-Propanetricarboxylic acid monohydrate
Molecular formula: C6H8O7H2O
Molecular weight: 210.14
Warnings and Restrictions: Where intended for topical use, sponsors should consider the impact of excipients on the sensitivity of the skin to sunlight and should ensure the finished product is safe for its intended purpose.
When used as an active ingredient in preparations for topical use, the medicine requires the following warning statements on the medicine label:
SENS – Application to skin may increase sensitivity to sunlight (or words to that effect).
SUNPRO – Wear protective clothing, hats and eyewear when exposed to the sun (or words to that effect).
IRRIT – If irritation develops, discontinue use.
SKTEST – If you have sensitive skin, test this product on a small area of skin before applying it to a large area.
CHILD3 – Use in children under 12 years is not recommended.
Allowable purpose of the ingredient: Active. Excipient
TGA reference: British Pharmacopoeia