drug facts

drug facts

SPL v2

SPL

SPL Set ID 97c19dca-237c-c968-e053-2a95a90aeae7

Route

topical

Published

Effective Date 2019-03-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

glycerin (2 g)

Inactive Ingredients

water stearic acid

Identifiers & Packaging

Marketing Status

unapproved drug other active Since 2019-11-16

Description

glycerin

Medication Information

Warnings and Precautions

■ if following abnormal symptoms occurs after use , stop use and consult with a skin specialist

red specks, swelling, itching

■ don’t use on the part where there is injury, eczema, or dermatitis

Keep out of reach of children

■ if swallowed, get medical help or contact a person control center immediately

Active Ingredient

glycerin

Indications and Usage

take a suitable amount on the skin

Dosage and Administration

for external use only

Description

glycerin

Section 50565-1

keep out of reach of the children

Section 51727-6

propylene glycol, steaqric acid, etc

Section 51945-4

Section 55105-1

for skin protectant

Structured Label Content

Warnings and Precautions (34071-1)

■ if following abnormal symptoms occurs after use , stop use and consult with a skin specialist

red specks, swelling, itching

■ don’t use on the part where there is injury, eczema, or dermatitis

Keep out of reach of children

■ if swallowed, get medical help or contact a person control center immediately

Active Ingredient (55106-9)

glycerin

Indications and Usage (34067-9)

take a suitable amount on the skin

Dosage and Administration (34068-7)

for external use only

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

propylene glycol, steaqric acid, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

for skin protectant

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "take a suitable amount on the skin", "34068-7": "for external use only", "34071-1": "■ if following abnormal symptoms occurs after use , stop use and consult with a skin specialist red specks, swelling, itching ■ don’t use on the part where there is injury, eczema, or dermatitis Keep out of reach of children ■ if swallowed, get medical help or contact a person control center immediately", "50565-1": "keep out of reach of the children", "51727-6": "propylene glycol, steaqric acid, etc", "55105-1": "for skin protectant", "55106-9": "glycerin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:15.204954 · Updated: 2026-03-14T23:03:12.694901