DRMITSUI VAGINAL PROBIOTICS- vaginal probiotics gel

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Rosa Rugosa Flower Water

Centella Asiatica Extract

Purslane (Portulaca Oleracea) Extract

PURPOSE

VAGINAL HEALTH

UNPLEASANT ODOR

VAGINAL MOISTURIZER

PH BALANCE RESTORER·

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

WARNINGS

For external use only. Discontinue useimmediately if an allergic reaction occurs.

INDICATIONS & USAGE

By forming a protective gel film on thevaginal wall, the product physically isolatesthe vaginal wall from external bacteria,thereby preventing the colonization ofpathogenic microorganisms. It is indicatedfor the adjunctive treatment of chroniccervicitis and vaginitis. The product issupplied non-sterile and is for single-use only.

DOSAGE & ADMINISTRATION

Clean the perineal area before use. Assumea squatting or lying position, relax yourbody, gently insert the applicator into thevagina, and gently dispense the gel. Useone applicator per night for a 7-daytreatment cycle.

INACTIVE INGREDIENT

Water, Longan (Euphoria Longana) FruitExtract, Glucose, Propylene Glycol, IsomaltOligosaccharide, Fructooligosaccharide,Inulin, Sodium Hyaluronate, HydrolysedSodium Hyaluronate, Hyaluronic Acid,Hydrolysed Hyaluronic Acid, AcetylatedSodium Hyaluronate, Cross-linked SodiumHyaluronate Polymer, Pro-vitamin B5,Rosa Rugosa Flower Water, CentellaAsiatica Extract, Purslane (PortulacaOleracea) Extract, Silver Lons, Carbomer,Triethanolamine.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DRMITSUI VAGINAL PROBIOTICS 
vaginal probiotics gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87267-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ROSA RUGOSA FLOWER BUD (UNII: TZ0BE8I3MW) (ROSA RUGOSA FLOWER BUD - UNII:TZ0BE8I3MW)	ROSA RUGOSA FLOWER BUD	5 g  in 100 g
PORTULACA OLERACEA SEED (UNII: M08917G08Z) (PORTULACA OLERACEA SEED - UNII:M08917G08Z)	PORTULACA OLERACEA SEED	3 g  in 100 g
CENTELLA ASIATICA ROOT (UNII: 8MXU1P42J0) (CENTELLA ASIATICA ROOT - UNII:8MXU1P42J0)	CENTELLA ASIATICA ROOT	3 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER (UNII: 0A5MM307FC)
DIMOCARPUS LONGAN SEED (UNII: 8VF8J08EB6)
FRUCTOSE PHENYLOSAZONE, DL- (UNII: 01KM283D85)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
DEXPANTHENOL (UNII: 1O6C93RI7Z)
LEVOGLUCOSE (UNII: 02833ISA66)
ISOMALTOSE (UNII: 67I334IX2M)
INULIN (UNII: JOS53KRJ01)
1-KESTOSE (UNII: 02LN7O412C)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM HYALURONATE CROSSPOLYMER-6 (UNII: 788QAG3W8A)
GLUCOSYLMANNITOL (UNII: G97P6S66E9)
SILVER (UNII: 3M4G523W1G)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
HYALURONIC ACID (UNII: S270N0TRQY)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87267-010-01	7 in 1 BOX	05/10/2026
1		3 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	05/10/2026

Labeler - YIYANGYUAN LIFE SCIENCES (HONG KONG) CO., LIMITED (765303678)