Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 6ca93c48-1930-5a79-e053-2991aa0a1685

Route

TOPICAL

Published

Effective Date 2018-05-24

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Glycerin (0.3 g)

Inactive Ingredients

Water Arginine

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2018-05-21

Description

glycerin

Medication Information

Warnings and Precautions

■store between 20-25 °C (68-77 °F)

■avoid freezing and excessive heat above 40 °C (104 °F)

Indications and Usage

apply proper amount to the skin

Dosage and Administration

keep out of eyes, ears and mouth, If contact occurs, rinse with plenty of worm or cold water right away and in a serious situation, contact a physician. If swallowing, drink plenty of water and contact a physician

Description

glycerin

Section 50565-1

keep out of reach of the children

Section 51727-6

water, hydrogenated polyisobutene, arginine, 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)

Warnings and Precautions (34071-1)

■store between 20-25 °C (68-77 °F)

■avoid freezing and excessive heat above 40 °C (104 °F)

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

water, hydrogenated polyisobutene, arginine, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

skin protectant

Section 55106-9 (55106-9)

glycerin

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ARGININE", "unii": "94ZLA3W45F", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "0.3", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "apply proper amount to the skin", "34068-7": "keep out of eyes, ears and mouth, If contact occurs, rinse with plenty of worm or cold water right away and in a serious situation, contact a physician. If swallowing, drink plenty of water and contact a physician", "34071-1": "■store between 20-25 °C (68-77 °F) ■avoid freezing and excessive heat above 40 °C (104 °F)", "50565-1": "keep out of reach of the children", "51727-6": "water, hydrogenated polyisobutene, arginine, etc", "55105-1": "skin protectant", "55106-9": "glycerin"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:34.268651 · Updated: 2026-03-14T22:55:07.187033