SPL v3
SPL
SPL Set ID 9ff2cb7b-b5ef-483c-9468-2726418c6537
Route
TOPICAL
Published
Effective Date 2009-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arbutin (0.6 mL) Glycerin (3 mL)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-11-01
Description

ACTIVE INGREDIENTS: Glycerin, EGF complex (EGF, IGF-1, bFGF, TRX, Acetyl Hexapeptide, Copper Tripeptide) 2.5%, Arbutin, Acerola Fruit extract

Medication Information

Description

ACTIVE INGREDIENTS: Glycerin, EGF complex (EGF, IGF-1, bFGF, TRX, Acetyl Hexapeptide, Copper Tripeptide) 2.5%, Arbutin, Acerola Fruit extract

Section 50565-1

Caution: For external use only.  Keep out of reach of children.  Discontinue use if irritation occurs.

Section 50567-7

DIRECTION OF USE:

After conditioning skin with Regulator(toner) pump the essence 2 to 3 times and smoothly spread on face and neck.  Avoid the eye area.  Gently tap the skin with fingers for complete absorption.

Section 51945-4


Label2c





Section 55106-9

ACTIVE INGREDIENTS:

Glycerin, EGF complex (EGF, IGF-1, bFGF, TRX, Acetyl Hexapeptide, Copper Tripeptide) 2.5%, Arbutin, Acerola Fruit extract

Structured Label Content

Section 50565-1 (50565-1)

Caution: For external use only.  Keep out of reach of children.  Discontinue use if irritation occurs.

Section 50567-7 (50567-7)

DIRECTION OF USE:

After conditioning skin with Regulator(toner) pump the essence 2 to 3 times and smoothly spread on face and neck.  Avoid the eye area.  Gently tap the skin with fingers for complete absorption.

Section 51945-4 (51945-4)


Label2c





Section 55106-9 (55106-9)

ACTIVE INGREDIENTS:

Glycerin, EGF complex (EGF, IGF-1, bFGF, TRX, Acetyl Hexapeptide, Copper Tripeptide) 2.5%, Arbutin, Acerola Fruit extract

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:54:58.362309 · Updated: 2026-03-14T22:52:13.708968