Female Intimate Hygiene Antibacterial Gels

Manufacturer
ShenZhen MengTi Biotechnology Co.Ltd | Yunnan Baifeng Pharmaceutical Co. Ltd
Effective date
2021-06-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:53

Label at a glance#

ProductFemale Intimate Hygiene Antibacterial Gels
Active ingredientBENZALKONIUM BROMIDE
Label structure13 sections

Dosage and administration

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.

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Female Intimate Hygiene Antibacterial Gels

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium bromide 0.10% w/w. Purpose: Antibiotic

Purpose

OTC - PURPOSE SECTION

Antibiotic, Female Intimate Hygiene Antibacterial Gels

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only
Disposable, do not reuse it

Do not use

OTC - DO NOT USE SECTION

  • during menstruation, pregnancy, or breastfeeding

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2211

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81983-101-022022-07-29C16284748780-1e4f33bdf-9ecc-d8a0-e053-dadaa90a6e4eFemale Intimate Hygiene Antibacterial Gels

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81983-101-01Female Intimate Hygiene Antibacterial Gels3.5 g in 1 BAGGEL3.51
81983-101-02Female Intimate Hygiene Antibacterial Gels10 in 1 BOXGEL101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81983-101FEMALE INTIMATE HYGIENE ANTIBACTERIAL GELS (BENZALKONIUM BROMIDE ) GEL [SHENZHEN MENGTI BIOTECHNOLOGY CO.LTD]1Legacy NDC, 2 package rows20210618_c43920ab-2925-2dd2-e053-2995a90a1df2.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81983-10181983-101-01, 81983-101-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

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
c43920ab-2917-2dd2-e053-2995a90a1df2c43920ab-2925-2dd2-e053-2995a90a1df22021-06-07WarningsExact identifier
spl id: c43920ab-2917-2dd2-e053-2995a90a1df2
spl set id: c43920ab-2925-2dd2-e053-2995a90a1df2

Reported adverse events (FAERS/openFDA)#

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