SPL v1
SPL
SPL Set ID 6dd4dbe0-aef3-5d6a-e053-2a91aa0aa106
Route
TOPICAL
Published
Effective Date 2018-06-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (10 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-06-04

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 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 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

apply proper amount to the skin

Dosage and Administration

external use only

Description

glycerin

Section 50565-1

Keep out of reach of children.

Section 51727-6

water, arginine, carbomer, etc

Section 51945-4

Section 55105-1

skin protectant

Section 55106-9

glycerin


Structured Label Content

Indications and Usage (34067-9)

apply proper amount to the skin

Dosage and Administration (34068-7)

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 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 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 children.

Section 51727-6 (51727-6)

water, arginine, carbomer, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

skin protectant

Section 55106-9 (55106-9)

glycerin


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)