FDA.reportPublic FDA data

MOUTH ULCER - Guangzhou Shengli Shidai Cosmetics Co., Ltd.

Manufacturer
Guangzhou Shengli Shidai Cosmetics Co., Ltd.
Effective date
2026-05-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-zip
Hydrated at
2026-05-27 18:02:33

Label at a glance#

ProductMOUTH ULCER
Active ingredientPANTHENOL
Label structure8 sections

Label contents#

Full prescribing information#

INACTIVE INGREDIENT SECTION

aqua
glycerin
propylene glycol
allantoin
polysorbate 20
sophora flavescens root extract
phenoxyethanol
ethylhexylglycerin
sodium citrate
menthol
citric acid

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older:eApply a small ámount directly to the affected area 3 to 4 times daily,or as needed,Do not eat or drink for at least 1 minute after application.Children under 12 years old should use under adult supervision.Children under 2 years: Do not use.

WARNINGS SECTION

It is contraindicated for individuals who are allergic to this product or any of its ingredients.

OTC - ACTIVE INGREDIENT SECTION

panthenol 1.2%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Please keep it out of reach of children to prevent them from taking or eating.

OTC - PURPOSE SECTION

Relieve oral discomfort

INDICATIONS & USAGE SECTION

For the temporary relief of pain due to canker sores, mínor irritation of the mouth and gums caused by dentures or orthodontic appliances, or minor injury of the mouth or gums.

Adults and children 2 years of age and older:eApply a small amount directly to the affected area 3 to 4 times daily,or as needed.Do not eat or drink for at least 1 minute after application.Children under 12 years old should use under adult supervision.Children under 2 years: Do not use.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label imageLabel image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87714-002-01MOUTH ULCER20 mL in 1 BOTTLELIQUID201

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87714-00287714-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
PANTHENOLWV9CM0O67ZACTIB
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM CITRATE1Q73Q2JULRIACT
MENTHOLL7T10EIP3AIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
CITRIC ACID2968PHW8QPIACT
POLYSORBATE 207T1F30V5YHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
AQUA059QF0KO0RIACT
ALLANTOIN344S277G0ZIACT

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
MOUTH ULCERPANTHENOLGuangzhou Shengli Shidai Cosmetics Co., Ltd.5264f81c-bffe-4f6d-e063-6394a90ae3bf2026-05-22WarningsExact identifier
ndc (package): 87714-002-01
ndc (product): 87714-002
ndc11 (package): 87714000201
spl id: 5264f81c-bfff-4f6d-e063-6394a90ae3bf
spl set id: 5264f81c-bffe-4f6d-e063-6394a90ae3bf

Reported adverse events (FAERS/openFDA)#

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