Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3e911ad6-52b0-5cd3-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (6.0192 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-08-11
Description

DIMETHICONE

Medication Information

Warnings and Precautions

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

Indications and Usage

Take appropriate amount of eye serum evenly spread on the skin

Dosage and Administration

for external use only

Description

DIMETHICONE

Section 50565-1

keep out of reach of the children

Section 51727-6

WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, GLYCERIN, TOCOPHEROL, ETC.

Section 51945-4

Section 55105-1

Skin Protectant

Section 55106-9

DIMETHICONE

Structured Label Content

Indications and Usage (34067-9)

Take appropriate amount of eye serum evenly spread on the skin

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).

1) Occurrence of red spots, swelling, itchiness, and other skin irritation

2) If the symptoms above occur after the application area is exposed to direct sunlight

2. Do not use on open wounds, eczema, and other skin irritations

3. Precaution for Storage and Handling

1) Close the lid after use

2) Keep out of reach of infants and children

3) Do not to store in a place with high/low temperature and exposed to direct sunlight

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

WATER, CYCLOPENTASILOXANE, BUTYLENE GLYCOL, GLYCERIN, TOCOPHEROL, ETC.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin Protectant

Section 55106-9 (55106-9)

DIMETHICONE

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:11.432758 · Updated: 2026-03-14T22:54:29.116843