The Melanin Skin Protectant Cream

The Melanin Skin Protectant Cream
SPL v1
SPL
SPL Set ID 3415fb52-47c5-0715-e063-6294a90a272c
Route
TOPICAL
Published
Effective Date 2025-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Allantoin (1 g)
Inactive Ingredients
Water

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Completed Since 2025-04-10 Until 2026-04-09

Description

Active Ingredients Allantoin


Medication Information

Warnings and Precautions

For external use only

Do not use on deep or puncture wounds, animal bites, or serious burns unless directed by a doctor

Discontinue use and consult a dermatologist if any of the following symptoms occur, as continued use may worsen the condition: 1) Red spots, swelling, itching, or irritation during use; 2) Similar symptoms appearing on the applied area due to direct sunlight exposure

Avoid contact with eyes; if contact occurs, rinse immediately

Keep out of reach of children

Store in a cool, dry place, away from direct sunlight and extreme temperatures

Indications and Usage

Temporarily protects and helps relieve minor skin irritations

Helps protect chapped or cracked skin

Description

Active Ingredients Allantoin

Section 43683-2

Newly added

Section 50565-1

KEEP OUT OF THE REACH OF CHILDREN.

Section 51727-6

Inactive ingredients:

Purified Water, Glycerin, Propylene Glycol, Laurocapram, Niacinamide, Xanthan Gum, Butylene Glycol, Tocopherol, Cetearyl Alcohol, Isohexadecane, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Cetearyl Glucoside, Polyacrylamide, C13-14 Isoparaffin, 1,2-Hexanediol, Disodium EDTA, Ergothioneine, Selaginella Tamariscina Extract, Ethylhexylglycerin, Glucose, Fragrance, Ginkgo Biloba Leaf Extract, Prunella Vulgairs Extract, Croton Lechleri Resin Extract

Section 55105-1

Temporarily protects and helps relieve minor skin irritations

Helps protect chapped or cracked skin

Section 55106-9

Active Ingredients

Allantoin

The Melanin Skin Protectant Cream

These Highlights Do Not Include All the Information Needed to Use. See Full Prescribing Information.

Apply as needed


Structured Label Content

Indications and Usage (34067-9)

Temporarily protects and helps relieve minor skin irritations

Helps protect chapped or cracked skin

Warnings and Precautions (34071-1)

For external use only

Do not use on deep or puncture wounds, animal bites, or serious burns unless directed by a doctor

Discontinue use and consult a dermatologist if any of the following symptoms occur, as continued use may worsen the condition: 1) Red spots, swelling, itching, or irritation during use; 2) Similar symptoms appearing on the applied area due to direct sunlight exposure

Avoid contact with eyes; if contact occurs, rinse immediately

Keep out of reach of children

Store in a cool, dry place, away from direct sunlight and extreme temperatures

Section 43683-2 (43683-2)

Newly added

Section 50565-1 (50565-1)

KEEP OUT OF THE REACH OF CHILDREN.

Section 51727-6 (51727-6)

Inactive ingredients:

Purified Water, Glycerin, Propylene Glycol, Laurocapram, Niacinamide, Xanthan Gum, Butylene Glycol, Tocopherol, Cetearyl Alcohol, Isohexadecane, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Hydrogenated Lecithin, Cetearyl Glucoside, Polyacrylamide, C13-14 Isoparaffin, 1,2-Hexanediol, Disodium EDTA, Ergothioneine, Selaginella Tamariscina Extract, Ethylhexylglycerin, Glucose, Fragrance, Ginkgo Biloba Leaf Extract, Prunella Vulgairs Extract, Croton Lechleri Resin Extract

Section 55105-1 (55105-1)

Temporarily protects and helps relieve minor skin irritations

Helps protect chapped or cracked skin

Section 55106-9 (55106-9)

Active Ingredients

Allantoin

The Melanin Skin Protectant Cream

These Highlights Do Not Include All the Information Needed to Use. See Full Prescribing Information. (These highlights do not include all the information needed to use. See full prescribing information.)

Apply as needed


Advanced Ingredient Data


Raw Label Data

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