Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID ba1b5380-b7bf-ed4d-e053-2995a90a4147

Route

TOPICAL

Published

Effective Date 2021-01-30

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Allantoin (0.5 g)

Inactive Ingredients

Glycerin Butylene Glycol Water

Identifiers & Packaging

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2021-01-30

Description

allantoin

Medication Information

Warnings and Precautions

For external use only.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications and Usage

clean face and pat dry.

pour toner onto the soft side onf pad or your palm and dab over the face, neck, and chest

(please refer to the directions on the label)

Dosage and Administration

for external use only

Description

allantoin

Section 50565-1

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6

water, glycerin, butylene glycol, etc.

Section 51945-4

Section 55105-1

skin protecttant, hydrate

Section 55106-9

allantoin

Structured Label Content

Indications and Usage (34067-9)

clean face and pat dry.

pour toner onto the soft side onf pad or your palm and dab over the face, neck, and chest

(please refer to the directions on the label)

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

For external use only.

When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water.

Stop use and ask a doctor if significant irritation or sensitization develops.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF THE CHILDREN

Section 51727-6 (51727-6)

water, glycerin, butylene glycol, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

skin protecttant, hydrate

Section 55106-9 (55106-9)

allantoin

Advanced Ingredient Data

[{"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLENE GLYCOL", "unii": "3XUS85K0RA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALLANTOIN", "unii": "344S277G0Z", "classCode": "ACTIB", "strengthNumerator": "0.5", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "clean face and pat dry. pour toner onto the soft side onf pad or your palm and dab over the face, neck, and chest (please refer to the directions on the label)", "34068-7": "for external use only", "34071-1": "For external use only. When using this product keep out of eyes. If contact with eyes occurs, rinse promptly and thoroughly with water. Stop use and ask a doctor if significant irritation or sensitization develops. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50565-1": "KEEP OUT OF REACH OF THE CHILDREN", "51727-6": "water, glycerin, butylene glycol, etc.", "55105-1": "skin protecttant, hydrate", "55106-9": "allantoin"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:59:21.469459 · Updated: 2026-03-14T22:59:16.552832