SPL v1
SPL
SPL Set ID 3aec3d85-c181-b995-e063-6394a90ad054
Route
TOPICAL
Published
Effective Date 2025-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Gentiana Scabra Root (1 g) Centella Asiatica (2 g) Glycerin (3 g) Glycyrrhiza Glabra Leaf (0.5 g) Salicylic Acid (0.8 g)
Inactive Ingredients
Rosmarinus Officinalis (rosemary) Leaf Powder Scutellaria Baicalensis Root Camellia Sinensis Root Matricaria Recutita Leaf Polygonum Cuspidatum Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-28
Description

GENTIANA SCABRA 1% CENTELLA ASIATICA、2% Glycerin,3% Glycyrrhiza glabr0.5% salicylic acid 0.8%

Medication Information

Warnings and Precautions

Warnings:Forexternal use only, Stop usingandask a doctor, ifrash orirritationhappens.

Indications and Usage

Directions:

1.Apply daily after cleansingandtoning Twice a day for at least 4weeks.2.Apply a pea-sized portion to thetarget area and massage gentlyuntilabsorbed.3.Keep usingit fora period oftimeuntil the milia have disappeared.

Dosage and Administration

Directions:

1.Apply daily after cleansingandtoning Twice a day for at least 4weeks.2.Apply a pea-sized portion to thetarget area and massage gentlyuntilabsorbed.3.Keep usingit fora period oftimeuntil the milia have disappeared.

Description

GENTIANA SCABRA 1% CENTELLA ASIATICA、2% Glycerin,3% Glycyrrhiza glabr0.5% salicylic acid 0.8%

Section 50565-1

Keep out ofreach ofchildren:Keepaway from children.

Section 50567-7

When usingthis product: Avoidcontact with eyes,ears, mouth or anyopen wounds.lf product getsintoeyes, rinseimmediately with water.

Section 51727-6

Inactive ingredient:

CAMELLIASINENSIS,CHAMOMILLARECUTITA,ROSMARINUSOFFICINALIS,POLYGONUMCUSPIDATUM,SCUTELLARIA

BAICALENSIS

Section 51945-4

Section 55105-1

FAT GRANULE CLEARING

SKIN ESSENCEDESIGNED TO DISSOLVEPROBLEMATIC MILIA

Section 55106-9

GENTIANA SCABRA 1%

CENTELLA ASIATICA、2%

Glycerin,3%

Glycyrrhiza glabr0.5%

salicylic acid 0.8%

Section 60561-8

Storage and Handling:Store in a cool place, away from directsunlight

Structured Label Content

Indications and Usage (34067-9)

Directions:

1.Apply daily after cleansingandtoning Twice a day for at least 4weeks.2.Apply a pea-sized portion to thetarget area and massage gentlyuntilabsorbed.3.Keep usingit fora period oftimeuntil the milia have disappeared.

Dosage and Administration (34068-7)

Directions:

1.Apply daily after cleansingandtoning Twice a day for at least 4weeks.2.Apply a pea-sized portion to thetarget area and massage gentlyuntilabsorbed.3.Keep usingit fora period oftimeuntil the milia have disappeared.

Warnings and Precautions (34071-1)

Warnings:Forexternal use only, Stop usingandask a doctor, ifrash orirritationhappens.

Section 50565-1 (50565-1)

Keep out ofreach ofchildren:Keepaway from children.

Section 50567-7 (50567-7)

When usingthis product: Avoidcontact with eyes,ears, mouth or anyopen wounds.lf product getsintoeyes, rinseimmediately with water.

Section 51727-6 (51727-6)

Inactive ingredient:

CAMELLIASINENSIS,CHAMOMILLARECUTITA,ROSMARINUSOFFICINALIS,POLYGONUMCUSPIDATUM,SCUTELLARIA

BAICALENSIS

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

FAT GRANULE CLEARING

SKIN ESSENCEDESIGNED TO DISSOLVEPROBLEMATIC MILIA

Section 55106-9 (55106-9)

GENTIANA SCABRA 1%

CENTELLA ASIATICA、2%

Glycerin,3%

Glycyrrhiza glabr0.5%

salicylic acid 0.8%

Section 60561-8 (60561-8)

Storage and Handling:Store in a cool place, away from directsunlight

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:37.898587 · Updated: 2026-03-14T23:09:31.593516