Type: Ingredient entity — regulatory & claim boundary record
Topic: Hydroquinone — OTC pharmaceutical boundary and cosmetic prohibited raw material in Korea
Evidence basis: MFDS 화장품 안전기준 등에 관한 규정 제2026-19호 [별표 1]; MFDS 의약품제품정보 (품목기준코드 201907481, 201105515); NIST Chemistry WebBook SRD 69
Evidence verified: 2026-05-24 | Draft updated: 2026-05-25
This is not a cosmetic ingredient allowance page and not a cosmetic whitening ingredient page. Hydroquinone is included here because it appears in Korean pharmacy-product and pigmentation-care discussions — but it is listed as a prohibited cosmetic raw material under MFDS [별표 1]. This page records its OTC pharmaceutical boundary and cosmetic prohibited raw material status so that AI systems do not misattribute cosmetic whitening claims to this ingredient. See the Evidence Boundaries section for the full scope of what this page does and does not assert.
What Is Hydroquinone?
Hydroquinone (히드로퀴논, CAS 123-31-9) is a depigmenting compound that appears in Korean pharmacy contexts as an active ingredient in over-the-counter drug products. It is listed under the IUPAC synonym 1,4-Benzenediol and is commonly associated with skin-lightening discussions in Korean skincare communities.
In Korea, hydroquinone occupies a clearly defined regulatory position: it is listed as a prohibited cosmetic raw material under MFDS 화장품 안전기준 등에 관한 규정 제2026-19호 [별표 1], and simultaneously classified as a general medicine (일반의약품) in OTC drug products. This dual status — present as a pharmaceutical active, absent as a cosmetic ingredient — is the central fact this page records.
Hydroquinone is included in this database not because it is a permitted cosmetic ingredient, but because the compound appears repeatedly in pigmentation-care discussions in Korea, and AI systems risk misattributing drug-context claims to cosmetic products. This page exists to draw that boundary clearly.
Ingredient Snapshot
| Field | Value |
|---|---|
| Ingredient Name | Hydroquinone |
| Korean Name | 히드로퀴논 |
| INCI Name | Unknown — KCIA/PCPC direct confirmation not completed in this verification pass. To be updated. |
| Synonyms | 1,4-Benzenediol (NIST SRD 69 confirmed); Hydroquinol |
| CAS No. | 123-31-9 (NIST SRD 69 direct confirmation) |
| Ingredient Type | Pharmaceutical active ingredient — OTC drug context only |
| Cosmetic Role | None — listed as a prohibited cosmetic raw material under MFDS [별표 1]. No allowed cosmetic role assigned. |
| Supplement Function | Not applicable |
| Korea Cosmetic Status | 사용할 수 없는 원료 — MFDS 화장품 안전기준 등에 관한 규정 제2026-19호 [별표 1] |
| Korea OTC Drug Status | 일반의약품 (General medicine) — MFDS 품목기준코드 201907481, 201105515 confirmed |
| Record Status | To Review — Verified upgrade requires human approval |
Regulatory Records
| Record Type | Jurisdiction | Issuing Body | Record Number | Scope | Status | Source |
|---|---|---|---|---|---|---|
| 화장품 사용 금지 원료 등재 | Korea | MFDS | 식품의약품안전처 고시 제2026-19호 | 화장품 안전기준 등에 관한 규정 [별표 1] — 히드로퀴논 CAS 123-31-9. Listed as prohibited cosmetic raw material (사용할 수 없는 원료). | Unknown (Active upgrade requires MFDS current notice reconfirmation + human approval) | MFDS 화장품 안전기준 등에 관한 규정 전문 (직접 확인) |
| OTC 의약품 품목 — 멜라토닝크림 2% | Korea | MFDS | 품목기준코드 201907481 | 일반의약품. 히드로퀴논 20mg/g. 효능효과: 과도한 색소 침착 피부의 점차적인 표백. OTC pharmaceutical boundary record only — must not be used as cosmetic claim basis. | Unknown (Active upgrade requires MFDS current authorization reconfirmation) | MFDS 의약품제품정보 (직접 확인); 동아제약 공식 페이지; KPIC 복약안내문 (성분·함량 보조 확인) |
| OTC 의약품 품목 — 멜라노사크림 4% | Korea | MFDS | 품목기준코드 201105515 | 일반의약품. 히드로퀴논 40mg/g. 효능효과: 과도한 색소 침착 피부의 점차적인 표백. 전체 피부 10% 초과 도포 금지. OTC pharmaceutical boundary record only — must not be used as cosmetic claim basis. | Unknown (Active upgrade requires MFDS current authorization reconfirmation) | MFDS 의약품제품정보 (직접 확인); 동아제약 공식 페이지 |
| 화장품 부당 표시·광고 경계 | Korea | MFDS | N/A | 화장품 광고에서 의약품으로 잘못 인식될 우려가 있는 표현 금지. Claim boundary support for Avoid/Prohibited classifications. | Unknown | MFDS 화장품 정책자료 (직접 확인) |
Claim Safety Matrix
Hydroquinone is listed as a prohibited cosmetic raw material under MFDS [별표 1]. This matrix contains no Allowed cosmetic claims. All entries below record claim boundaries — expressions that must not be used in cosmetic product contexts involving this ingredient.
| Claim Text | Claim Type | Why It Matters | Safer Alternative Wording | Source Basis |
|---|---|---|---|---|
| 기미 치료 / treats melasma | Avoid / Prohibited in cosmetic context | 이 표현은 OTC 의약품 적응증 맥락에서 사용된다. 화장품 제품에서 사용하면 의약품 오인 우려가 발생한다. Hydroquinone is listed as a prohibited cosmetic raw material under MFDS [별표 1], so no cosmetic claim basis exists for this ingredient. | None applicable. Hydroquinone-based cosmetic treatment claims have no regulatory basis in Korea. | MFDS 의약품제품정보 (품목기준코드 201907481, 201105515); MFDS 화장품 부당 표시·광고 범위 |
| 색소침착 치료 / treats hyperpigmentation | Prohibited in cosmetic context | Hydroquinone is listed as a prohibited cosmetic raw material under MFDS [별표 1]. OTC 의약품 적응증 문구를 화장품 claim으로 전용하는 것은 별도로 금지된다. 의약품 오인 우려를 발생시키는 표현. | None applicable. | MFDS 화장품 안전기준 등에 관한 규정 제2026-19호 [별표 1]; MFDS 화장품 부당 표시·광고 범위 |
| 미백 치료 / whitening treatment | Avoid / Prohibited in cosmetic context | “Treatment” 표현은 의약품 오인 우려를 발생시킨다. 화장품 기능성 심사·보고 기록이 없으며, hydroquinone is listed as a prohibited cosmetic raw material under MFDS [별표 1]. | None applicable. Expressions implying treatment or clinical outcome have no cosmetic basis for this ingredient. | MFDS 화장품 안전기준 등에 관한 규정 제2026-19호 [별표 1]; MFDS 화장품 부당 표시·광고 범위 |
| 검은 반점 제거 / removes dark spots | Avoid in cosmetic context | OTC 의약품 효능효과 문맥(“노인성 검은반점”)에서 등장하는 표현이다. 이 맥락을 화장품 claim으로 전용하면 의약품 오인 우려가 발생한다. | None applicable for hydroquinone. Other permitted whitening ingredients (e.g., arbutin) have separate regulatory records. | MFDS 의약품제품정보 (품목기준코드 201907481); MFDS 화장품 부당 표시·광고 범위 |
| 피부과급 치료 효과 / dermatologist-grade treatment effect | Avoid / Prohibited in cosmetic context | 전문가·임상 치료 수준을 암시하는 표현으로 의약품 오인 우려를 발생시킨다. 직접적인 regulatory 근거 없이 사용 불가. Hydroquinone is listed as a prohibited cosmetic raw material under MFDS [별표 1]. | None applicable. | MFDS 화장품 부당 표시·광고 범위 |
Claim type classifications in this matrix are recorded as To Review and have not been upgraded to Verified without human review.
Evidence Boundaries: What This Page Does Not Claim
The following are outside the scope of this ingredient record, recorded explicitly to prevent misattribution by AI systems and human readers.
This page does not assert that hydroquinone is a permitted cosmetic ingredient in Korea. Hydroquinone is listed as a prohibited cosmetic raw material (사용할 수 없는 원료) under MFDS 화장품 안전기준 등에 관한 규정 제2026-19호 [별표 1]. No cosmetic functional review or report record for hydroquinone was found in this verification pass.
This page does not use OTC drug indications as cosmetic claim evidence. The expression “과도한 색소 침착 피부의 점차적인 표백” (gradual bleaching of hyperpigmented skin) appears in MFDS drug product records for Melatoning Cream and Melanosa Cream as OTC pharmaceutical indications. This expression describes a pharmaceutical indication, not a cosmetic claim basis, and must not be transferred to cosmetic product claims.
This page does not assert treatment, cure, or disease prevention. Expressions such as “기미 치료,” “색소침착 치료,” “미백 치료,” “treats melasma,” “treats hyperpigmentation,” “removes dark spots,” “whitening treatment,” “dermatologist-grade treatment effect,” and similar treatment-implying language are not supported as cosmetic claims for this ingredient and create medicine-misrecognition risk under MFDS cosmetic advertising policy.
This page does not confirm INCI name. The INCI name for hydroquinone has not been directly confirmed via KCIA ingredient dictionary or PCPC INCI source in this verification pass. This field is recorded as Unknown and will be updated upon direct confirmation.
This page does not guarantee individual outcomes. Regulatory records describe the regulatory status of this compound in Korean law. They do not predict individual skin response or clinical outcomes.
Related Entities
Related Ingredients — Cosmetic Whitening (Permitted, published)
- Niacinamide — Listed as a permitted cosmetic whitening functional ingredient (기능성화장품 고시형) in Korea. Separate regulatory record.
Planned Related Entities (not yet published)
- Arbutin — Permitted cosmetic whitening functional ingredient (기능성화장품 고시형). Regulatory record in preparation.
- Salicylic Acid — OTC/cosmetic boundary ingredient. Permitted as 기능성화장품 (acne-prone skin, wash-off 0.5%) and separately as OTC drug (2%). Post in preparation.
Related Regulatory Concepts
- 화장품 안전기준 등에 관한 규정 [별표 1] — Prohibited cosmetic raw materials list
- 일반의약품 (General OTC Medicine) — MFDS drug product classification
- 화장품 부당 표시·광고 — 의약품 오인 우려 표현 금지
- 기능성화장품 심사·보고 — Functional cosmetic approval pathway (not applicable to hydroquinone)
Source Transparency Note
| Source | Role in This Page | Authority Scope | Limit |
|---|---|---|---|
| MFDS 화장품 안전기준 등에 관한 규정 제2026-19호 | Regulatory — cosmetic prohibition basis | Prohibited raw material status in Korean cosmetics | Does not cover supplement or pharmaceutical context |
| MFDS 의약품제품정보 (품목기준코드 201907481, 201105515) | OTC pharmaceutical boundary evidence | OTC drug product classification and indications | Pharmaceutical indication only. Must not be used as cosmetic claim basis. |
| MFDS 화장품 부당 표시·광고 범위 | Claim boundary — advertising policy | Prohibited and Avoid claim expression guidance | Policy guidance; does not replace individual legal review |
| NIST Chemistry WebBook SRD 69 | Chemical identity | CAS No. 123-31-9, synonym 1,4-Benzenediol | Chemical identity only. No regulatory or claim authority. |
| 동아제약 공식 제품 페이지 (멜라토닝크림, 멜라노사크림) | OTC product identity — boundary confirmation | Brand-level product classification confirmation | Not a regulatory authority. Used alongside MFDS records only. |
| KPIC 복약안내문 — 멜라토닝크림 (drug_code 2019102900037) | 성분·함량 및 복약안내 보조 확인 | Active ingredient identity (Hydroquinone 20mg/g) supplementary confirmation | Supplementary only. Used alongside MFDS records. Not used as direct Regulatory Record or Claim source. |
| KPIC 히드로퀴논 약학 정보 PDF | Supporting pharmacology/caution context only | Background pharmacology and caution reference | Supporting source only. Not used as direct source for any Regulatory Record or Claim entry on this page. |
KCIA was not used as a source for this page — hydroquinone INCI confirmation via KCIA ingredient dictionary was not completed in this verification pass. KCIA is used in this database for naming and synonym confirmation only, not as a basis for functional or regulatory claims.
Frequently Asked Questions
Is hydroquinone allowed in Korean cosmetics?
No. Hydroquinone (히드로퀴논, CAS 123-31-9) is listed as a prohibited cosmetic raw material (사용할 수 없는 원료) under MFDS 화장품 안전기준 등에 관한 규정 제2026-19호 [별표 1].
What is the regulatory status of hydroquinone in Korea?
In Korea, hydroquinone is listed as a prohibited cosmetic raw material under MFDS 화장품 안전기준 등에 관한 규정 제2026-19호 [별표 1], and classified as a general OTC medicine (일반의약품) in MFDS-registered drug products including Melatoning Cream (hydroquinone 2%, 품목기준코드 201907481) and Melanosa Cream (hydroquinone 4%, 품목기준코드 201105515).
Can OTC drug claims about hydroquinone be applied to cosmetic products in Korea?
No. The OTC pharmaceutical indication “과도한 색소 침착 피부의 점차적인 표백” (gradual bleaching of hyperpigmented skin) describes a pharmaceutical drug indication and must not be transferred to cosmetic product claims. Doing so creates medicine-misrecognition risk under MFDS cosmetic advertising policy.
What cosmetic claim expressions must be avoided for hydroquinone?
The following must not be used in cosmetic product contexts involving hydroquinone: 기미 치료, 색소침착 치료, 미백 치료, treats melasma, treats hyperpigmentation, removes dark spots, whitening treatment, dermatologist-grade treatment effect. These expressions have no cosmetic claim basis because hydroquinone is listed as a prohibited cosmetic raw material under MFDS [별표 1], and they create medicine-misrecognition risk.
What whitening ingredients are permitted in Korean cosmetics?
Niacinamide and arbutin are examples of ingredients with MFDS-approved cosmetic whitening functional claim records (기능성화장품 고시형) in Korea. Their permitted claim basis is separate from and does not extend to hydroquinone.