Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 7ced5492-9ef6-4c0b-b040-d5dae08e4501

Route

TOPICAL

Published

Effective Date 2010-04-09

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Arbutin (2.1 g)

Inactive Ingredients

Water Glycerin Alcohol Capric Acid Glyceryl Monostearate Cetostearyl Alcohol Silicon Dioxide Polyethylene Glycol 2-ethylhexanoic Acid Dimethicone Methylparaben Betaine Trolamine Propylparaben Ethylparaben Dipropylene Glycol Carbomer 934 Edetate Trisodium Fd&c Yellow No. 6 Fd&c Yellow No. 5

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2010-03-29

Description

ARBUTIN 2.10g/100g

Medication Information

Description

ARBUTIN 2.10g/100g

Section 43685-7

For external use only

Section 50565-1

Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use if a rash or irritation develops and lasts.

Section 50567-7

Keep out of eyes. Rinse with water to remove.

Section 51945-4

Section 55106-9

ARBUTIN 2.10g/100g

Structured Label Content

Section 43685-7 (43685-7)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use if a rash or irritation develops and lasts.

Section 50567-7 (50567-7)

Keep out of eyes. Rinse with water to remove.

Section 51945-4 (51945-4)

Section 55106-9 (55106-9)

ARBUTIN 2.10g/100g

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"43685-7": "For external use only", "50565-1": "Keep out of reach of children. Is swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use if a rash or irritation develops and lasts.", "50567-7": "Keep out of eyes. Rinse with water to remove.", "55106-9": "ARBUTIN 2.10g/100g"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:02.403716 · Updated: 2026-03-14T22:52:21.082332