SPL v1
SPL
SPL Set ID 803fbf23-8b47-1530-e053-2991aa0ab5f1
Route
TOPICAL
Published
Effective Date 2019-01-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (10 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-01-24

Description

Open the lid, press the lid to fill the dropper and apply evenly 3-4 drops to the desired parts, gently tap with the fingers to allow it to absorb


Medication Information

Warnings and Precautions

Discontinue use of the product if any of the following symptoms occurred. Consult a dermatologist if the symptoms got worse.

a) If redness, Swelling, Itchiness, Irritation occurred during using.

b) If the above symptoms started to occur when exposed to direct sunlight.

Do not use on skins with wounds, eczema or dermatitis.

Storage instructions

a) Always close the lid after finish using.

b) Store in a safe place away and out of reach of children.

c) Store in a place with not too high or low temperature, keep awayfrom direct sunlight exposure.

Indications and Usage

Open the lid, press the lid to fill the dropper and apply evenly 3-4 drops to the desired parts, gently tap with the fingers to allow it to absorb

Dosage and Administration

for external use only

Description

Open the lid, press the lid to fill the dropper and apply evenly 3-4 drops to the desired parts, gently tap with the fingers to allow it to absorb

Section 50565-1

Keep out of reach of children.

Section 51727-6

water, butylene glycol, hyaluronic acid, alcohol, etc.

Section 51945-4

Section 55105-1

Ampoule with human stem-cell-culture fluids and EGF that helps improving skin texture

Section 55106-9

glycerin


Structured Label Content

Indications and Usage (34067-9)

Open the lid, press the lid to fill the dropper and apply evenly 3-4 drops to the desired parts, gently tap with the fingers to allow it to absorb

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

Discontinue use of the product if any of the following symptoms occurred. Consult a dermatologist if the symptoms got worse.

a) If redness, Swelling, Itchiness, Irritation occurred during using.

b) If the above symptoms started to occur when exposed to direct sunlight.

Do not use on skins with wounds, eczema or dermatitis.

Storage instructions

a) Always close the lid after finish using.

b) Store in a safe place away and out of reach of children.

c) Store in a place with not too high or low temperature, keep awayfrom direct sunlight exposure.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

water, butylene glycol, hyaluronic acid, alcohol, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Ampoule with human stem-cell-culture fluids and EGF that helps improving skin texture

Section 55106-9 (55106-9)

glycerin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)