SPL v2
SPL
SPL Set ID 389e27c8-f16a-4028-92b4-813a26114d15
Route
TOPICAL
Published
Effective Date 2025-06-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (5 mg)
Inactive Ingredients
Colloidal Silver Water Tocopherol Madecassoside Centella Asiatica Whole Sodium Hyaluronate Honey Polysorbate 60 Cetearyl Alcohol Mineral Oil White Petrolatum Glycerin Lavandula Angustifolia (lavender) Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-02

Description

Active ingredient: Allantoin 0.5%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Uses:

  • Temporarily protects minor cuts, scrapes, and burns
  • Helps relieve skin irritation associated with bed sores, pressure ulcers, or cracked skin
  • Aids in the healing of wounds by forming a protective moisture barrier
Dosage and Administration

Directions:

  • Clean the affected area
  • Apply a thin layer to the affected area 2 to 3 times daily or as directed by a physician
  • May be covered with a sterile bandage or left uncovered
Description

Active ingredient: Allantoin 0.5%

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

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
  • You are allergic to any of the ingredients in this product
Section 50567-7

When using this product

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Section 50569-3

Ask a doctor before use if you have:

A serious wound or condition that requires medical attention

Section 50570-1

Do not use:

  • On deep or puncture wounds
  • On animal bites
  • On serious burns
Section 51727-6

Inactive ingredients:

  • Colloidal Silver
  • Water
  • Tocopherol
  • Madecassoside
  • Centella Asiatica Whole
  • Sodium Hyaluronate
  • Honey
  • Polysorbate 60
  • Cetearyl Alcohol
  • Mineral Oil
  • White Petrolatum
  • Glycerin
  • Lavandula Angustifolia (Lavender) Oil
Section 53413-1

Questions or comments?

Contact us at [email protected]

Section 53414-9

If pregnant or breast-feeding

Ask a health professional before use

Section 55105-1
  • Skin Protectant
Section 55106-9

Active ingredient:

  • Allantoin 0.5%
Section 60561-8

Other information:

  • Store at 15°–30°C (59°–86°F)
  • Avoid freezing and direct sunlight
  • Tamper-evident: Do not use if seal under cap is broken or missing
Package Label.principal Display Panel


Structured Label Content

Indications and Usage (34067-9)

Uses:

  • Temporarily protects minor cuts, scrapes, and burns
  • Helps relieve skin irritation associated with bed sores, pressure ulcers, or cracked skin
  • Aids in the healing of wounds by forming a protective moisture barrier
Dosage and Administration (34068-7)

Directions:

  • Clean the affected area
  • Apply a thin layer to the affected area 2 to 3 times daily or as directed by a physician
  • May be covered with a sterile bandage or left uncovered
Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

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
  • You are allergic to any of the ingredients in this product
Section 50567-7 (50567-7)

When using this product

Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Section 50569-3 (50569-3)

Ask a doctor before use if you have:

A serious wound or condition that requires medical attention

Section 50570-1 (50570-1)

Do not use:

  • On deep or puncture wounds
  • On animal bites
  • On serious burns
Section 51727-6 (51727-6)

Inactive ingredients:

  • Colloidal Silver
  • Water
  • Tocopherol
  • Madecassoside
  • Centella Asiatica Whole
  • Sodium Hyaluronate
  • Honey
  • Polysorbate 60
  • Cetearyl Alcohol
  • Mineral Oil
  • White Petrolatum
  • Glycerin
  • Lavandula Angustifolia (Lavender) Oil
Section 53413-1 (53413-1)

Questions or comments?

Contact us at [email protected]

Section 53414-9 (53414-9)

If pregnant or breast-feeding

Ask a health professional before use

Section 55105-1 (55105-1)
  • Skin Protectant
Section 55106-9 (55106-9)

Active ingredient:

  • Allantoin 0.5%
Section 60561-8 (60561-8)

Other information:

  • Store at 15°–30°C (59°–86°F)
  • Avoid freezing and direct sunlight
  • Tamper-evident: Do not use if seal under cap is broken or missing
Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)


Advanced Ingredient Data


Raw Label Data

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