UREA PEROXIDE

US FDA substance register · UNII 31PZ2VAU81 · registered name CARBAMIDE PEROXIDE · single chemical substance

Source: US FDA Unique Ingredient Identifier (UNII)

Restricted

China · South Korea · Taiwan

Source: Health Canada Cosmetic Ingredient Hotlist · MFDS (Korea) cosmetic regulatory information

Argentina · Brazil

• Field of application and/or use : (a) Products for hair care (b) Products for skin care (c) Products to toughen nails d) Products for oral hygiene
• Maximum concentration permitted at final product : (a) 12% H2O2 (40 volumes) present or released (b) 4% H2O2 present or released (c) 2% H2O2 present or released d) 0,1% H2O2 present or released
• Use conditions and warnings that must appear on the label : a) Contains hydrogen peroxide - Avoid contact with eyes. In case of contact with eyes thoroughly rinse with water - Use suitable gloves b) and c) - Contains hydrogen peroxide - Avoid contact with eyes. In case of contact with eyes thoroughly rinse with water

ASEAN

• Field of application and/or use : (a) Hair-care preparations (b) Skin-care preparations (c) Nail hardening preparations (d) Oral hygiene products (e) Tooth-whitening products (i) For use by the consumer under the supervision of a qualified dental practitioner. (ii) For application by a qualified dental practitioner only
• Maximum authorised concentration in the finished cosmetic product : (a) 12% H202 (40 volumes) present or released (b) 4% H202 present or released (c) 2% H202 present or released (d) ≤ 0.1% H202 present or released (e) Tooth-whitening products (i) >0.1 to ≤ 6% H202 present or released (ii)> 6 to 35 % H202 present or released
• Other limitations and requirements : (e) Tooth-whitening products (i) For supply only through a qualified dental practitioner. Not for direct sale to the general public (ii) Only to be used by a qualified dental practitioner. Not for direct sale to the general public.
• Conditions of use and warning which must be printed on the labels : (a) (b) (c) • Contains hydrogen peroxide. • Avoid contact with eyes. • Rinse eyes immediately if product comes into contact with them. (a) Wear suitable gloves. (e) Tooth-whitening products (i) Not for direct sale to the public. For supply only through qualified dental practitioner. Read & follow the instructions and use the product accordingly. Do not use the product within two weeks prior to, or immediately after dental restoration. Not for use by pregnant women or habitual tobacco and/or alcohol users. Stop using immediately if you experience any tooth sensitivity, gum irritation, toothache, defective restorations, gingivitis, nausea etc. Store out of reach of children. (ii) Not for direct sale to the public. Only to be used by a qualified dental practitioner. Do not use the product within two weeks prior to, or immediately after dental restoration. Not for use by pregnant women or habitual tobacco and/or alcohol users. Stop using immediately in cases of tooth sensitivity, gum irritation, toothache, defective restorations, gingivitis, nausea etc.

Canada

• Conditions of Use by product type : Oral products containing peroxides or peroxide-generating compounds: Manufacturers should have the following information on hand as it may be requested by Health Canada: 1. A laboratory report providing pH of the product as applied to tooth or teeth. Section 13 of the Cosmetic Regulations requires that the pH is greater than or equal to 4.0 2. Product labelling indicating the directions of use and cautionary statements. 3. If an oral cosmetic contains more than 3% hydrogen peroxide (or equivalent), notifiers must submit a clinical study to demonstrate the salivary peroxide levels do not exceed 3% during the use of the product as per the directions of use. NB: Be aware of the conversion factor between hydrogen peroxide and other peroxide‐generating compounds. For example, 10% carbamide (ure(a) peroxide is approximately equivalent to 3% hydrogen peroxide.
• Warnings and Cautionary Statements: (to the effect of) : “If irritation (such as redness, swelling, soreness) of the gums or the mouth occurs, discontinue use and consult an oral health professional.” “Products containing peroxides are not recommended for use by children under 12 years ofage.” “Consult your oral health professional before prolonged use of this product.” “Avoid swallowing the cosmetic or part thereof.” “Avoid contact of the product with the eye.” “Avoid direct contact of the active surface of the tooth whitening product with the gums and/or salivary flow."

European Union

• Product Type, body parts : (a) Hair products (b) Skin products (c) Nail hardening products (d) Oral products, including mouth rinse, tooth paste and tooth whitening or bleaching products (e) Tooth whitening or bleaching products (f) Products intended for eyelashes
• Maximum concentration in ready for use preparation : (a) 12% of H2O2 (40 volumes), present or released (b) 4% of H2O2, present or released (c) 2% of H2O2, present or released (d) ≤ 0,1 % of H 2O 2, present or released e) > 0,1 % ≤ 6 % of H2O2, present or released (f) 2 % of H 2O 2, present or released
• Other : (e) To be only sold to dental practitioners. For each cycle of use, first use by dental practitioners as defined under Directive 2005/36/EC (*) or under their direct supervision if an equivalent level of safety is ensured. Afterwards to be provided to the consumer to complete the cycle of use. Not to be used on a person under 18 years of age. (f) For professional use only
• Wording of conditions of use and warnings : (a) (f) Wear suitable gloves (a) (b) (c) (e) Contains hydrogen peroxide Avoid contact with eyes Rinse immediately if product comes into contact with them. (e) Concentration of H2O2 present or released indicated in percentage. Not to be used on a person under 18 years of age. To be only sold to dental practitioners. For each cycle of use, the first use to be only done by dental practitioners or under their direct supervision if an equivalent level of safety is ensured. Afterwards to be provided to the consumer to complete the cycle of use. f) To be printed on the label: ‘For professional use only. Avoid contact with eyes. Rinse eyes immediately if product comes into contact with them. Contains hydrogen peroxide

Korea’s toxic-substance GHS classification: Danger · H272 (category 3) · H314 (category 1)

Source: Korea toxic substances GHS register (NIER)

Restriction III/12 · Other restriction: ban substances that deplete the ozone layer

Source: EU CosIng ingredient list