Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 76d3ad33-3f2f-585a-e053-2991aa0a3e57
Route
TOPICAL
Published
Effective Date 2016-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Glycerin (0.045 g)
Inactive Ingredients
Water Butylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-09-01

Description

Glycerin


Medication Information

Warnings and Precautions

1) If following symptoms occur after product use, stop using immediately and consult with a specialist: red spots, swelling, itchiness, and other skin irritations. 2) Avoid contact with eyes and open wounds. 3) Keep out of reach of children. 4) Do not store at high/low temperature. 5) Avoid direct sunlight.

Indications and Usage

Apply an appropriate amount to skin and absorb it.

Dosage and Administration

for external use only



Description

Glycerin

Section 50565-1

keep out of reach of the children

Section 51727-6

WATER, 1,2-HEXANEDIOL, ADENOSINE, BUTYLENE GLYCOL, ETC.

Section 51945-4

Section 55105-1

Skin protectant

Section 55106-9

Glycerin


Structured Label Content

Indications and Usage (34067-9)

Apply an appropriate amount to skin and absorb it.

Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)

1) If following symptoms occur after product use, stop using immediately and consult with a specialist: red spots, swelling, itchiness, and other skin irritations. 2) Avoid contact with eyes and open wounds. 3) Keep out of reach of children. 4) Do not store at high/low temperature. 5) Avoid direct sunlight.

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

WATER, 1,2-HEXANEDIOL, ADENOSINE, BUTYLENE GLYCOL, 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)