drug facts

drug facts

SPL v1

SPL

SPL Set ID c8b14b2a-5ce0-3a33-e053-2a95a90a679f

Route

topical

Published

Effective Date 2019-03-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

glycerin (8 g)

Inactive Ingredients

water allantoin

Identifiers & Packaging

Marketing Status

otc monograph not final active Since 2021-08-04

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

shake the container for 2 to 3 times before use, apply it evenly

Dosage and Administration

for external use only

Description

glycerin

Section 50565-1

keep out of reach of the children

Section 51727-6

WATER, ALCOHOL, BUTYLENE GLYCOL, ETC

Section 51945-4

Section 55105-1

for skin protectant

relieve itchiness by providing moisture and nutrients to the dry skin

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)

shake the container for 2 to 3 times before use, apply it evenly

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)

WATER, ALCOHOL, BUTYLENE GLYCOL, ETC

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

for skin protectant

relieve itchiness by providing moisture and nutrients to the dry skin

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "shake the container for 2 to 3 times before use, apply it evenly", "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": "WATER, ALCOHOL, BUTYLENE GLYCOL, ETC", "55105-1": "for skin protectant relieve itchiness by providing moisture and nutrients to the dry skin", "55106-9": "glycerin"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:38.942599 · Updated: 2026-03-14T22:59:44.713365