Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID db520c80-2a2a-5eb1-e053-2995a90a5bb4

Route

TOPICAL

Published

Effective Date 2022-03-29

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Edetic Acid (0.05 g) Urea (4 g) Aloe Vera Leaf (0.5 g) Glycerin (8 g)

Inactive Ingredients

Water

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2019-08-22

Description

urea, glycerin, aloe barbadensis leaf extract, disodium edta

Medication Information

Warnings and Precautions

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

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

Indications and Usage

taking off an appropriate amount

you apply to your rough feet as you massage two or three times a day

Dosage and Administration

for topical use only

Description

urea, glycerin, aloe barbadensis leaf extract, disodium edta

Section 50565-1

keep out of reach of the children

Section 51727-6

Water, macadamia ternifolia seed oil, stearic acid, shea butter, etc

Section 51945-4

Section 55105-1

dead skin cell care cream

Section 55106-9

urea, glycerin, aloe barbadensis leaf extract, disodium edta

Structured Label Content

Indications and Usage (34067-9)

taking off an appropriate amount

you apply to your rough feet as you massage two or three times a day

Dosage and Administration (34068-7)

for topical use only

Warnings and Precautions (34071-1)

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

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)

Water, macadamia ternifolia seed oil, stearic acid, shea butter, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

dead skin cell care cream

Section 55106-9 (55106-9)

urea, glycerin, aloe barbadensis leaf extract, disodium edta

Advanced Ingredient Data

[{"name": "EDETIC ACID", "unii": "9G34HU7RV0", "classCode": "ACTIM", "strengthNumerator": "0.05", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "UREA", "unii": "8W8T17847W", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "ACTIB", "strengthNumerator": "8", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "taking off an appropriate amount you apply to your rough feet as you massage two or three times a day", "34068-7": "for topical use only", "34071-1": "don’t use on the part where there is injury, eczema, or dermatitis if swallowed, get medical help or contact a person control center immediately", "50565-1": "keep out of reach of the children", "51727-6": "Water, macadamia ternifolia seed oil, stearic acid, shea butter, etc", "55105-1": "dead skin cell care cream", "55106-9": "urea, glycerin, aloe barbadensis leaf extract, disodium edta"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:00:10.304829 · Updated: 2026-03-14T23:00:32.199749