UREA PEROXIDE

米国FDA 物質登録 · UNII 31PZ2VAU81 · 登録名 CARBAMIDE PEROXIDE · 単一の化学物質

出典: 米国FDA 物質識別番号（UNII）

制限

韓国 · 中国

出典: カナダ 禁止・制限成分リスト · 韓国食薬処 化粧品規制情報

アルゼンチン · ブラジル

• 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.

カナダ

• 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."

台湾

• ※ 特定用途化粧品之外包裝或容器，應明顯標示本表所列成分之注意事項。因外包裝或容器表面積過小或其他特殊情形致不能標示者，應於標籤、仿單或以其他方式刊載之。
• 用途 : 美白牙齒
• 最大配合量 : 居家使用之美白牙齒產品 : 18.0％
• 2. 使用時如有牙齒敏感現象,請暫停使用,並諮詢牙醫師。
• 3. 12 歲以下孩童,孕婦或授乳期婦女,不建議使用。
• 4. 牙齦組織或口腔有病變,以及對本產品之成分有過敏者,請勿使用。
• 5. 避免不當吞食。
• 6. 使用時避免本產品接觸眼睛,若不慎觸及眼睛,請立即用清水沖洗。
• 7. 使用牙齒美白劑期間不宜抽煙或嚼檳榔。
• 8. 使用時儘量避免讓本產品直接接觸到牙齦。
• 9. 使用超過 14 天以上,應依照牙醫師指示使用。
• 10.本產品需置於孩童接觸不到的地方及避免陽光直射

欧州連合

• 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

韓国の有害物質GHS分類: 危険 · H272 (区分3) · H314 (区分1)

出典: 韓国 有害物質GHS情報（環境公団）

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

出典: EU CosIng 成分リスト