Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 627811f6-9265-61f0-e053-2991aa0af310
Route
TOPICAL
Published
Effective Date 2016-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (0.8 g)
Inactive Ingredients
Water Aloe Vera Leaf Tartaric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-01-01
Description

Glycerin

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

1. Unfold the tissue and wet it slightly with water.

2. Take the slightly wet tissue and do flexing motions to make the tissue foam.

3. Softly wipe makeup away from the face.

4. Rinse face with warm water.

Dosage and Administration

for external use only

Description

Glycerin

Section 50565-1

keep out of reach of the children

Section 51727-6

Water, Hamamelis Virginiana (Witch Hazel) extract, Terminalia Ferdinandiana Fruit extract, Malpighia Emarginata (Acerola) Fruit extract, etc.

Section 51945-4

Section 55105-1

Skin protectant: Cleansing

Section 55106-9

Glycerin

Structured Label Content

Indications and Usage (34067-9)

1. Unfold the tissue and wet it slightly with water.

2. Take the slightly wet tissue and do flexing motions to make the tissue foam.

3. Softly wipe makeup away from the face.

4. Rinse face with warm water.

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, Hamamelis Virginiana (Witch Hazel) extract, Terminalia Ferdinandiana Fruit extract, Malpighia Emarginata (Acerola) Fruit extract, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Skin protectant: Cleansing

Section 55106-9 (55106-9)

Glycerin

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:36.217818 · Updated: 2026-03-14T22:55:11.113899