Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 56ffc0e0-2693-3c90-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2017-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (2 g)
Inactive Ingredients
Water Allantoin Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-08-17

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

4. Use as avoiding eye areas.

Indications and Usage

once or twice daily, place 3~5 drops in palm of hand

apply to areas and then massage the serum in

Dosage and Administration

for external use only

Description

glycerin

Section 50565-1

keep out of reach of the children

Section 51727-6

wter butylene glycol, allantoin etc

Section 51945-4

Section 55105-1

lifting, firming, reshaping

Section 55106-9

glycerin


Structured Label Content

Indications and Usage (34067-9)

once or twice daily, place 3~5 drops in palm of hand

apply to areas and then massage the serum in

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

4. Use as avoiding eye areas.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

wter butylene glycol, allantoin etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

lifting, firming, reshaping

Section 55106-9 (55106-9)

glycerin


Advanced Ingredient Data


Raw Label Data

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