Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID ec6e2256-a9cb-4b5a-940e-fb2f4a340064

Route

TOPICAL

Published

Effective Date 2014-10-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Glycerin (2 g)

Inactive Ingredients

Azelaic Acid Hyaluronate Sodium

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2014-10-15

Description

glycerin

Medication Information

Warnings and Precautions

- avoid direct sun exposure, keep it refrigerated or in cooler places

- avoid contact with eye

Indications and Usage

apply appropriate to skin

Dosage and Administration

for exernal use only

Description

glycerin

Section 50565-1

keep out or reach of the children

Section 51727-6

triethanolamine, azelaic acid, portulaca oleracea ext, propolis ext, sodium hyaluronate, polyglutamic acid

Section 51945-4

Section 55105-1

skin protectant

Section 55106-9

glycerin

Structured Label Content

Indications and Usage (34067-9)

apply appropriate to skin

Dosage and Administration (34068-7)

for exernal use only

Warnings and Precautions (34071-1)

- avoid direct sun exposure, keep it refrigerated or in cooler places

- avoid contact with eye

Section 50565-1 (50565-1)

keep out or reach of the children

Section 51727-6 (51727-6)

triethanolamine, azelaic acid, portulaca oleracea ext, propolis ext, sodium hyaluronate, polyglutamic acid

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

skin protectant

Section 55106-9 (55106-9)

glycerin

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}, {"name": "AZELAIC ACID", "unii": "F2VW3D43YT", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYALURONATE SODIUM", "unii": "YSE9PPT4TH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"34067-9": "apply appropriate to skin", "34068-7": "for exernal use only", "34071-1": "- avoid direct sun exposure, keep it refrigerated or in cooler places - avoid contact with eye", "50565-1": "keep out or reach of the children", "51727-6": "triethanolamine, azelaic acid, portulaca oleracea ext, propolis ext, sodium hyaluronate, polyglutamic acid", "55105-1": "skin protectant", "55106-9": "glycerin"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:50.978417 · Updated: 2026-03-14T22:53:51.342349