Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID f441f544-012e-3d36-e053-2995a90ab758
Route
TOPICAL
Published
Effective Date 2016-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.05 g)
Inactive Ingredients
Water 1,2-hexanediol

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2017-04-09
Description

Allantoin 0.5%

Medication Information

Warnings and Precautions

1. For external use only.

1) Do not use over the wound and irritated skin with eczema or infections

2) Discontinue using the product if signs of irritations and/or rashes occur and seek professional medical help

2. Keep the cover closed tight after use

3. Do not put the left over contents back into the container to avoid deterioration

1) Avoid contact with eyes

2) Keep out of reach of children

3) Store in a cool and dry place, away from direct sun light

Indications and Usage

Apply to skin and wipe

Dosage and Administration

for external use only



Description

Allantoin 0.5%

Section 50565-1

keep out of reach of the children

Section 51727-6

Water, etc

Section 51945-4

Section 55105-1

wet tissue

Section 55106-9

Allantoin 0.5%

Structured Label Content

Indications and Usage (34067-9)

Apply to skin and wipe

Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)

1. For external use only.

1) Do not use over the wound and irritated skin with eczema or infections

2) Discontinue using the product if signs of irritations and/or rashes occur and seek professional medical help

2. Keep the cover closed tight after use

3. Do not put the left over contents back into the container to avoid deterioration

1) Avoid contact with eyes

2) Keep out of reach of children

3) Store in a cool and dry place, away from direct sun light

Section 50565-1 (50565-1)

keep out of reach of the children

Section 51727-6 (51727-6)

Water, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

wet tissue

Section 55106-9 (55106-9)

Allantoin 0.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:22.769512 · Updated: 2026-03-14T23:09:06.809873