Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 523b6598-8039-4116-b0f8-ba31d7d6ea9d
Route
TOPICAL
Published
Effective Date 2024-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.6 g)
Inactive Ingredients
Yellow Wax Calendula Officinalis Flower Coconut Oil Comfrey Root Cottonseed Oil Jojoba Oil Magnesium Oxide Palm Oil Peppermint Oil Sage Oil Silver Stearate Sunflower Oil Tea Tree Oil Thuja Occidentalis Leaf Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-18
Description

Allantoin 0.6%                                 Skin Protectant

Purpose

Allantoin 0.6%                                 Skin Protectant

Medication Information

Purpose

Allantoin 0.6%                                 Skin Protectant

Description

Allantoin 0.6%                                 Skin Protectant

Uses

Helps prevent, temporarily protect, and relieve chapped or cracked skin.

Section 50565-1

Section 55105-1

Warnings

For external use only. When using this product, do not get into eyes.

Stop use and ask a doctor if

  • condition worsens 
  • symptoms last more than 7 days  
  • symptoms clear up and occur again within a few days.

Consult a doctor before using

  • on deep or puncture wounds
  • animal bites 
  • serious burns. 

Keep out of reach of children. If swallowed, call Poison Control or seek medical help.

Directions

Wash and dry affected skin. Apply an ample amount of ointment. Cover with a clean bandage as needed. Repeat procedure 1 to 3 times daily until skin improves or as directed by a doctor.

Product Label

Other Information

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Inactive Ingredients

beeswax, calendula extract, coconut oil (organic), comfrey extract, cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, sunflower oil, tea tree oil, thuja extract, zinc oxide

Active Ingredient                                  purpose

Allantoin 0.6%                                 Skin Protectant

Structured Label Content

Uses

Helps prevent, temporarily protect, and relieve chapped or cracked skin.

Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Warnings

For external use only. When using this product, do not get into eyes.

Stop use and ask a doctor if

  • condition worsens 
  • symptoms last more than 7 days  
  • symptoms clear up and occur again within a few days.

Consult a doctor before using

  • on deep or puncture wounds
  • animal bites 
  • serious burns. 

Keep out of reach of children. If swallowed, call Poison Control or seek medical help.

Directions

Wash and dry affected skin. Apply an ample amount of ointment. Cover with a clean bandage as needed. Repeat procedure 1 to 3 times daily until skin improves or as directed by a doctor.

Product Label (Product label)

Other Information (Other information)

Store at room temperature. May temporarily (washable) discolor skin and fabrics in sunlight.

Inactive Ingredients

beeswax, calendula extract, coconut oil (organic), comfrey extract, cottonseed oil, jojoba oil, magnesium oxide, MCT oil, peppermint oil, sage oil, silver stearate, sunflower oil, tea tree oil, thuja extract, zinc oxide

Active Ingredient                                  purpose (Active Ingredient                                  Purpose)

Allantoin 0.6%                                 Skin Protectant

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:53.912863 · Updated: 2026-03-14T23:02:40.652524