SPL v1
SPL
SPL Set ID 461a1c95-6564-9dd8-e063-6294a90a83e7
Route
TOPICAL
Published
Effective Date 2025-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (0.6 g)
Inactive Ingredients
Lithospermum Erythrorhizon Root Calendula Officinalis Flower .alpha.-bisabolol, (+/-)- Tremella Fuciformis Whole Geniposide Lonicera Japonica Flower Matrine Helichrysum Italicum Flower Matricaria Chamomilla Whole Phellodendron Amurense Bark Centella Asiatica Triterpenoids Glycerin Water Panax Notoginseng Root Hydroxyacetophenone Beeswax Medium-chain Triglycerides Jojoba Oil Coconut Oil Panthenol Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-16

Description

Drug Facts

Purpose

Skin protectant


Medication Information

Purpose

Skin protectant

Description

Drug Facts

Uses
  • helps prevent and temporarily protects chafed, chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
Warnings

​For external use only.

Directions

apply as needed

Drug Facts

Drug Facts

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

Allantoin 0.6%

Other Information

store at room temperature

Inactive Ingredients

Water, Beeswax, Jojoba Oil, Coconut Oil, Medium-Chain Triglycerides (MCT Oil), Panax Notoginseng Extract (Panax Notoginseng Root), Lithospermum Root Extract (Lithospermum Erythrorhizon Root), Honeysuckle Flower Extract (Lonicera Japonica Flower), Calendula Extract (Calendula Officinalis Flower), Immortelle (Helichrysum) Extract (Helichrysum Italicum Flower), Phellodendron Bark Extract (Phellodendron Amurense Bark), Centella Asiatica Extract (Centella Asiatica Triterpenoids), Chamomile Extract (Matricaria Chamomilla Whole), Bisabolol (Alpha-Bisabolol (+/-)), Tremella Polysaccharide (Tremella Fuciformis Whole), Geniposide, Matrine (Sophora Flavescens Alkaloid), Panthenol (Vitamin B5), Vitamin E (Tocopherol), Glycerin, Hydroxyacetophenone.

Principal Display Panel

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
  • helps prevent and temporarily protects chafed, chapped or cracked skin
  • helps protect from the drying effects of wind and cold weather
Purpose

Skin protectant

Warnings

​For external use only.

Directions

apply as needed

Drug Facts

Drug Facts

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

Allantoin 0.6%

Other Information (Other information)

store at room temperature

Inactive Ingredients (Inactive ingredients)

Water, Beeswax, Jojoba Oil, Coconut Oil, Medium-Chain Triglycerides (MCT Oil), Panax Notoginseng Extract (Panax Notoginseng Root), Lithospermum Root Extract (Lithospermum Erythrorhizon Root), Honeysuckle Flower Extract (Lonicera Japonica Flower), Calendula Extract (Calendula Officinalis Flower), Immortelle (Helichrysum) Extract (Helichrysum Italicum Flower), Phellodendron Bark Extract (Phellodendron Amurense Bark), Centella Asiatica Extract (Centella Asiatica Triterpenoids), Chamomile Extract (Matricaria Chamomilla Whole), Bisabolol (Alpha-Bisabolol (+/-)), Tremella Polysaccharide (Tremella Fuciformis Whole), Geniposide, Matrine (Sophora Flavescens Alkaloid), Panthenol (Vitamin B5), Vitamin E (Tocopherol), Glycerin, Hydroxyacetophenone.

Principal Display Panel

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

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