FDA.reportPublic FDA data

84895-103-02

Manufacturer
Advaccine Biopharmaceuticals Suzhou Co., Ltd | Advaccine Biologics Suzhou Co.，Ltd.
Effective date
2025-12-22
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:52:12

Label at a glance#

ProductDissolvable Microneedle Eye Patches
Active ingredientALLANTOIN
Label structure8 sections

Indications and uses

Temporarily protects (and helps relieve) chapped or cracked skin. helps protect from the drying effects of wind and cold weather

Dosage and administration

· apply as needed · clean and dry affected area · apply 1 patch and press firmly for 15 seconds · leave in place up to 6 hours · remove and discard

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Allantoin 1%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects (and helps relieve) chapped or cracked skin.

helps protect from the drying effects of wind and cold weather

Directions

DOSAGE & ADMINISTRATION SECTION

· apply as needed

· clean and dry affected area

· apply 1 patch and press firmly for 15 seconds

· leave in place up to 6 hours

· remove and discard

Warnings

WARNINGS SECTION

For external use only

Do not use

on deep or puncture wounds

animal bites

serious burns

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Glycerin，Glycyrrhizate Dipotassium，Hyaluronate Sodium，Propylene Glycol，Sucrose

84895-103-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

frontfrontobverseobverse

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2739739allantoin 1 % Medicated PatchPSN3
2739739allantoin 0.01 MG/MG Medicated PatchSCD3
2739739allantoin 1 % Medicated PatchSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128CODE 12884895-103-02_02.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84895-103-02Dissolvable Microneedle Eye Patches45 mg in 1 PATCHPATCH453
84895-103-02Dissolvable Microneedle Eye Patches2 in 1 PACKETPATCH23

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84895-10384895-103-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYALURONATE SODIUMYSE9PPT4THIACT
GLYCERINPDC6A3C0OXIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
SUCROSEC151H8M554IACT
ALLANTOIN344S277G0ZACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dissolvable Microneedle Eye PatchesALLANTOINAdvaccine Biopharmaceuticals Suzhou Co., Ltd4684fa4e-5c5e-045d-e063-6394a90af0692025-12-22WarningsExact identifier
ndc (package): 84895-103-02
ndc (product): 84895-103
ndc11 (package): 84895010302
spl id: 4687644f-3c8c-eb88-e063-6394a90a00cc
spl set id: 4684fa4e-5c5e-045d-e063-6394a90af069

Reported adverse events (FAERS/openFDA)#

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