Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 84b9f4ae-b82e-089a-e053-2a91aa0ad230

Route

TOPICAL

Published

Effective Date 2019-03-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Glycerin (0.2 g)

Inactive Ingredients

Water Aloe Vera Leaf

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2019-03-23

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

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

aloe barbadensis leaf extract, alcohol, butylene glycol, etc

Section 51945-4

Section 55105-1

for skin protectant

Section 55106-9

glycerin

Structured Label Content

Indications and Usage (34067-9)

take a suitable amount on the skin

Dosage and Administration (34068-7)

for external use only

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

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

aloe barbadensis leaf extract, alcohol, butylene glycol, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

for skin protectant

Section 55106-9 (55106-9)

glycerin

Advanced Ingredient Data

[{"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "0.2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

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": "aloe barbadensis leaf extract, alcohol, butylene glycol, etc", "55105-1": "for skin protectant", "55106-9": "glycerin"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:56:47.044736 · Updated: 2026-03-14T22:55:27.684543