Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 83f4bfbb-47d8-4fe9-ba33-85142ec6221c
Route
TOPICAL
Published
Effective Date 2024-12-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (5 mg)
Inactive Ingredients
Dimethicone Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Sunflower Oil Hydrogenated Jojoba Oil, Randomized Helianthus Annuus Seed Wax Acacia Decurrens Flower Wax Polyglycerin-3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-06-01
Description

Allantoin 0.5%

Purpose

Skin protectant

Medication Information

Purpose

Skin protectant

Description

Allantoin 0.5%

Uses

temporarily protects minor:

  • cuts
  • scrapes
  • burns
Section 51945-4

Warnings

For external use only

Directions

● apply as needed

Do Not Use On
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient

Allantoin 0.5%

Inactive Ingredients

dimethicone, dimethicone crosspolymer, helianthus annuus (sunflower) seed oil unsaponifiables, silica silylate, acrylates/dimethicone copolymer, jojoba esters, helianthus annuus (sunflower) seed wax, acacia decurrens flower wax, polyglycerin-3

Questions Or Comments?

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

When Using This Product

do not get into eyes

Stop Use and Ask A Doctor If
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Uses

temporarily protects minor:

  • cuts
  • scrapes
  • burns
Section 51945-4 (51945-4)

Purpose

Skin protectant

Warnings

For external use only

Directions

● apply as needed

Do Not Use On (Do not use on)
  • deep or puncture wounds
  • animal bites
  • serious burns
Active Ingredient (Active ingredient)

Allantoin 0.5%

Inactive Ingredients (Inactive ingredients)

dimethicone, dimethicone crosspolymer, helianthus annuus (sunflower) seed oil unsaponifiables, silica silylate, acrylates/dimethicone copolymer, jojoba esters, helianthus annuus (sunflower) seed wax, acacia decurrens flower wax, polyglycerin-3

Questions Or Comments? (Questions or comments?)

Call 1-800-811-1660

Monday - Friday (9 a.m. - 5 p.m. CST)

When Using This Product (When using this product)

do not get into eyes

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:05:07.577077 · Updated: 2026-03-14T23:06:27.679265