Aluroderm Scar Patch

Manufacturer: Olakino Therapeutics LLC
Effective date: 2025-02-07
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 00:54:42

Label at a glance#

ProductAluroderm Scar

Active ingredientALLANTOIN

Label structure14 sections

Indications and uses

-Scar Management -Temporarily protects and helps relieve chapped or cracked skin

Dosage and administration

Adults and Children 12 Years of Age and Older -Clean and dry the affected area -Apply as needed

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Allantoin 0.75%

PURPOSE

OTC - PURPOSE SECTION

Skin Protectant

USES

INDICATIONS & USAGE SECTION

-Scar Management

-Temporarily protects and helps relieve chapped or cracked skin

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY

DO NOT USE

OTC - DO NOT USE SECTION

-On deep punctures, serious burns, or infected skin

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

Avoid contact with the eyes

STOP USE AND ASK DOCTOR IF

OTC - STOP USE SECTION

-Condition worsens

-Excessive skin irritation develops

-Condition persists for more than 7 days, or condition clears up and occurs again within 3 days

IF PREGNANT OR BREASTFEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a physician before use

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, seek medical help or contact Poison Control immediately

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and Children 12 Years of Age and Older

-Clean and dry the affected area

-Apply as needed

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

-Store at room temperature

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Hyaluronic Acid, Taxifolin, Polyurethane, Sodium Carboxymethyl Cellulose

QUESTIONS OR COMMENTS

SPL UNCLASSIFIED SECTION

info@olakinotherapeutics.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pouch

box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
2711688	allantoin 0.75 % Medicated Patch	PSN	2
2711688	allantoin 0.0075 MG/MG Medicated Patch	SCD	2
2711688	allantoin 0.75 % Medicated Patch	SY	2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
84991-0316-1	Aluroderm Scar	5 in 1 POUCH	PATCH	5	2
84991-0316-1	Aluroderm Scar	1 in 1 BOX	PATCH	1	2
84991-0316-5	Aluroderm Scar	5 in 1 POUCH	PATCH	5	2
84991-0316-5	Aluroderm Scar	8.5 g in 1 PATCH	PATCH	8.5	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84991-0316	ALURODERM SCAR (ALLANTOIN) PATCH [OLAKINO THERAPEUTICS LLC]	2	Current NDC, 4 package rows	20250210_2a848dde-8fc4-ab10-e063-6294a90a2583.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
84991-0316-1	EA - Each	84991-0316	b16dde49-d6b5-4fb3-b54d-a484f7ce4e62	1	2025-03-04

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

Aluroderm Scar
allantoin
CARBOXYMETHYLCELLULOSE SODIUM
HYALURONIC ACID
TAXIFOLIN
POLYURETHANE-39

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
84991-0316	84991-0316-1, 84991-0316-5

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ALLANTOIN	344S277G0Z	ACTIB
CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	IACT
HYALURONIC ACID	S270N0TRQY	IACT
TAXIFOLIN	9SOB9E3987	IACT
POLYURETHANE-39	J9PXX566KC	IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aluroderm Scar	ALLANTOIN	Olakino Therapeutics LLC	2a848dde-8fc4-ab10-e063-6294a90a2583	2025-02-07	Warnings	Exact identifier ndc (package): 84991-0316-5 ndc (package): 84991-0316-1 ndc (product): 84991-0316 ndc11 (package): 84991031605 ndc11 (package): 84991031601 spl id: 2d94d970-563c-466c-e063-6294a90a93db spl set id: 2a848dde-8fc4-ab10-e063-6294a90a2583

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.