SPL v1
SPL
SPL Set ID 41652c38-145f-062b-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2010-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (3.5 g)
Inactive Ingredients
Water Panthenol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2016-10-01

Description

Glycerin


Medication Information

Indications and Usage

- Wet the whole body and lather well on a shower sponge, a towel, or hands and massage the whole body gently and wash away with water cleanly.

- For a bath, you can enjoy a refreshing enzymatic bath by lathering enough in warm water.

* Shake well before use.

Dosage and Administration

For the external use only

Description

Glycerin

Section 50565-1

Keep out of reach of children.

Section 51727-6

Sea Water, Water, Lauryl Glucoside, Decyl Glucoside, Pentylene Glycol, Laminaria Japonica Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Butylene Glycol, Panthenol, etc.

Section 51945-4

Section 55105-1

Cleanse, moisturize, and smoothen sensitive baby's skin gently.

Section 55106-9

Glycerin

Warnings

1. Stop using the product if there are any of the following abnormal symptoms appearing after use and consult with your dermatologist as continued use can worsen the symptoms.

1) If there are red spots, swelling, itchiness, or irritation

2) If the above symptoms appear around the skin to which the product has been applied after being exposed to direct sunlight.

2. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis.

3. If it gets into eye, wash the eye with clean water immediately.

4. Wash away with water enough after use since not enough rinsing can lead to hair loss or discoloration.

5. Those who are allergic to certain medicinal herb, such as pollen and tangerine, must stop using the product if they experience hypersensitivity. 6. Precautions on storage and handling

1) Make sure to close the cap after use.

2) Keep out of the reach of children.

3) Do not keep the product in a hot or cold place or a place getting direct sunlight.


Structured Label Content

Indications and Usage (34067-9)

- Wet the whole body and lather well on a shower sponge, a towel, or hands and massage the whole body gently and wash away with water cleanly.

- For a bath, you can enjoy a refreshing enzymatic bath by lathering enough in warm water.

* Shake well before use.

Dosage and Administration (34068-7)

For the external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Sea Water, Water, Lauryl Glucoside, Decyl Glucoside, Pentylene Glycol, Laminaria Japonica Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Butylene Glycol, Panthenol, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Cleanse, moisturize, and smoothen sensitive baby's skin gently.

Section 55106-9 (55106-9)

Glycerin

Warnings (WARNINGS)

1. Stop using the product if there are any of the following abnormal symptoms appearing after use and consult with your dermatologist as continued use can worsen the symptoms.

1) If there are red spots, swelling, itchiness, or irritation

2) If the above symptoms appear around the skin to which the product has been applied after being exposed to direct sunlight.

2. Do not apply the product to any parts of the skin with wound, eczema, or dermatitis.

3. If it gets into eye, wash the eye with clean water immediately.

4. Wash away with water enough after use since not enough rinsing can lead to hair loss or discoloration.

5. Those who are allergic to certain medicinal herb, such as pollen and tangerine, must stop using the product if they experience hypersensitivity. 6. Precautions on storage and handling

1) Make sure to close the cap after use.

2) Keep out of the reach of children.

3) Do not keep the product in a hot or cold place or a place getting direct sunlight.


Advanced Ingredient Data


Raw Label Data

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