FDA.reportPublic FDA data

SmileCare Mouth Ulcer Gel

Manufacturer
Yantai Aien Biotechnology Co., Ltd.
Effective date
2026-03-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:50:56

Label at a glance#

ProductSmileCare Mouth Ulcer Gel
Active ingredientMENTHOL
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient
Purpose
Menthol(0.1%)...... Oral pain reliever

OTC - PURPOSE SECTION

Uses
Temporarily relieves occasional
minor irritation and pain
associated with sore mouth and
sore throat.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

Apply a small amount
of gel to the affected area of the
mouth. Gargle, swish around, or
allow to remain in place at least 1
minute and then spit out. Use up
to 4 times daily or as directed by a
dentist or doctor.

WARNINGS SECTION

Warnings
Do not use
In children under 2 years of age
unless directed by a doctor
Sore throat warnings
1If sore throat is severe, persists for
more than 2 days, is accompanied
or followed by fever, headache,
rash, swelling, nausea, or
vomiting, consult a doctor
promptly. These may be serious.

INDICATIONS & USAGE SECTION

Directions
Adults and children 2 years of ageand older: Apply a small amountof gel to the affected area of themouth. Gargle, swish around, orallow to remain in place at least 1minute and then spit out. Use upto 4 times daily or as directed by adentist or doctor.Children under 12 years of ageshould be supervised in the use of
this product.Children under 2 years of age:Consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients
Polihexanide, Riboflavin, Ferrous
Sulfate, Sorbitol, Sodium Alginate,
Glycerin, Niacinamide, Carbomer
Homopolymer, Trolamine, Water

87512-004-01 SmileCare Mouth Ulcer Gel 10g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

87512-004-0187512-004-01

87512-004-02 SmileCare Mouth Ulcer Gel 15g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

87512-004-0287512-004-02

87512-004-03 SmileCare Mouth Ulcer Gel 20g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

87512-004-0387512-004-03

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87512-004-01SmileCare Mouth Ulcer Gel10 g in 1 TUBEGEL101
87512-004-02SmileCare Mouth Ulcer Gel15 g in 1 TUBEGEL151
87512-004-03SmileCare Mouth Ulcer Gel20 g in 1 TUBEGEL201

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87512-00487512-004-01, 87512-004-02, 87512-004-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM ALGINATEC269C4G2ZQIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AACTIB
RIBOFLAVINTLM2976OFRIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
NIACINAMIDE25X51I8RD4IACT
POLIHEXANIDE322U039GMFIACT
SORBITOL506T60A25RIACT
FERROUS SULFATE39R4TAN1VTIACT

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
SmileCare Mouth Ulcer GelMENTHOLYantai Aien Biotechnology Co., Ltd.4d6db039-5b97-8f3f-e063-6294a90a9d852026-03-19WarningsExact identifier
ndc (package): 87512-004-02
ndc (package): 87512-004-01
ndc (package): 87512-004-03
ndc (product): 87512-004
ndc11 (package): 87512000402
ndc11 (package): 87512000403
ndc11 (package): 87512000401
spl id: 4d6db039-5b98-8f3f-e063-6294a90a9d85
spl set id: 4d6db039-5b97-8f3f-e063-6294a90a9d85

Reported adverse events (FAERS/openFDA)#

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