MOUTH ULCER- panthenol liquid

Drug Labeling and Warnings

Drug Details [pdf]

INACTIVE INGREDIENT

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

DOSAGE & ADMINISTRATION

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

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

ACTIVE INGREDIENT

panthenol 1.2%

KEEP OUT OF REACH OF CHILDREN

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

PURPOSE

Relieve oral discomfort

INDICATIONS & USAGE

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MOUTH ULCER 
panthenol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87714-002
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	1.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
MENTHOL (UNII: L7T10EIP3A)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
CITRIC ACID (UNII: 2968PHW8QP)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
AQUA (UNII: 059QF0KO0R)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87714-002-01	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/22/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	05/22/2026

Labeler - Guangzhou Shengli Shidai Cosmetics Co., Ltd. (443941288)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou Shengli Shidai Cosmetics Co., Ltd.		443941288	manufacture(87714-002) , label(87714-002)