rule 149
permission of the licensing authority.
The Drugs and Cosmetics Act and RulesPart XV Part XV
Hair dyes containing Para-Phenylenediamine or other Dyes, Colours and Pigments shall be labelled with the following legend in English and local languages and these shall appear on both the inner and the outer labels. “Caution—This product contains ingredients which may cause skin irritation in certain cases and so a preliminary test according to the accompanying direction should first be made. This product should not be used for dyeing the eye-lashes or eye-brows; as such a use may cause blindness”. Each package shall also contain instructions in English and local languages on the following lines for carrying out the test: “This preparation may cause serious inflammation of the skin in some cases and so a preliminary test should always be carried out to determine whether or not special sensitivity exists. To make the test, cleanse a small area of skin behind the ear or upon the inner surface of the forearm, using either soap and water or alcohol. Apply a small quantity of the hair dye as prepared for use to the area and allow it to dry. After twenty-four hours, wash the area gently with soap and water. If no irritation or inflammation is apparent, it may be assumed that no hypersensitivity to the dye exists. The test should, however, be carried out before each and every application. This preparation should on no account be used for dyeing eye-brows or eye-lashes as severe inflammation of the eye or even blindness may result.
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