FEMALE INTIMATE HYGIENE ANTIBACTERIAL GELS- benzalkonium bromide gel

Female Intimate Hygiene Antibacterial Gels by

Drug Labeling and Warnings

Female Intimate Hygiene Antibacterial Gels by is a Otc medication manufactured, distributed, or labeled by ShenZhen MengTi Biotechnology Co.Ltd, Yunnan Baifeng Pharmaceutical Co. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Female Intimate Hygiene Antibacterial Gels

Active Ingredient(s)

Benzalkonium bromide 0.10% w/w. Purpose: Antibiotic

Purpose

Antibiotic, Female Intimate Hygiene Antibacterial Gels

Use

for vagina to inhibit Staphylococcus aureus, Escherichia coli and Candida albicans.This product is not a substitute for medicines.

Warnings

For external use only
Disposable, do not reuse it

Do not use

• during menstruation, pregnancy, or breastfeeding

WHEN USING

do not get into eyes
if contact occurs, rinse eyes throughly with water

STOP USE

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Wash hands and clean the vulva
• Remove the front cover of the gel and insert the removed front cover into the rear end of the gel tube as a push rod
• Lie on your back and push the gel into the vagina with the gel pusher
• Take out the gel pusher, and lie still for three minutes.

Other information

• Store between 15-30C (59-86F)
• Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

Sophora Flavescens Root Extract, Averrhoa Carambola Fruit
Extract, Glycine Max (Soybean) Seed Extract, Pyrus Pyrifolia Fruit Extract

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

FEMALE INTIMATE HYGIENE ANTIBACTERIAL GELS 
benzalkonium bromide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81983-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM BROMIDE (UNII: 151T1GQ42D) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM BROMIDE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
NASHIPATI (UNII: SHY4TJD066)
SOPHORA FLAVESCENS WHOLE (UNII: X8KX602M5L)
STAR FRUIT (UNII: G00N2E9394)
SOYBEAN (UNII: L7HT8F1ZOD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81983-101-02	10 in 1 BOX	06/08/2021
1	NDC: 81983-101-01	3.5 g in 1 BAG; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/08/2021

Labeler - ShenZhen MengTi Biotechnology Co.Ltd (705839690)

Establishment
Name	Address	ID/FEI	Business Operations
Yunnan Baifeng Pharmaceutical Co. Ltd		731098614	manufacture(81983-101)