84642-001 (HYDROGEL ESSENCE Antimicrobial Virginal Gel)

Manufacturer
Guangdong Amoreneg Medicine Research and Development Co., LTD
Effective date
2024-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:17:15

Label at a glance#

ProductHYDROGEL ESSENCE Antimicrobial Virginal Gel.
Active ingredientCHLORHEXIDINE ACETATE
Label structure8 sections

Dosage and administration

Aduits and children 12 years of age and over: Thoroughly clean the vulva.Take one tube of the product and remove the cap from the gel applicator. Lie flat on your back. Gently insert the applicator into the vagina and push the hydrogel inside. Remain lying still for 2 minutes to allow the hydrogel to set and transition from liquid to gel format at body temperature.Children under 12 years of age: ask a doctor

Storage and handling

Store the product at room temperature for convenience. For optimail results, store between 4°C and 20°C

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine acetate 0.15%

Purpose

OTC - PURPOSE SECTION

Vaginal Antiseptic

Use

INDICATIONS & USAGE SECTION

Inhibitory microorganisms: Escherichia coli, Staphylococcus aureus, Candida albican

Warnings

WARNINGS SECTION

■ For vaginal use only;

■ Do not take orally;

■ Avoid co-use with antagonistic drugs;

■ It shall not be used for the prevention of sexually transmitted diseases during sexual life.

Stop use and ask a doctor

OTC - STOP USE SECTION

if you get a rash or hives, abdominal pain,fever, chills, nausea, vomiting, or a foul-smelling vaginal discharge.

If pregnant or nreast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Aduits and children 12 years of age and over: Thoroughly clean the vulva.Take one tube of the product and remove the cap from the gel applicator. Lie flat on your back. Gently insert the applicator into the vagina and push the hydrogel inside. Remain lying still for 2 minutes to allow the hydrogel to set and transition from liquid to gel format at body temperature.Children under 12 years of age: ask a doctor

Storage

STORAGE AND HANDLING SECTION

Store the product at room temperature for convenience.
For optimail results, store between 4°C and 20°C

Inactive ingredients

INACTIVE INGREDIENT SECTION

Chitosan, Poloxamer 407 and Zinc Chloride

label&pack

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8464284642

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORHEXIDINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84642-001-012025-07-29C16284748780-13b156c62-2760-fb37-e063-e6dba90a4e0784642-001 (HYDROGEL ESSENCE Antimicrobial Virginal Gel)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84642-001-01HYDROGEL ESSENCE Antimicrobial Virginal Gel.3.5 g in 1 TUBEGEL3.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84642-001HYDROGEL ESSENCE ANTIMICROBIAL VIRGINAL GEL. (CHLORHEXIDINE ACETATE) GEL [GUANGDONG AMORENEG MEDICINE RESEARCH AND DEVELOPMENT CO., LTD]11 package rows20240816_1fb2e6a7-7182-c36a-e063-6394a90ad980.zip

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84642-00184642-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 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
1fb2e6a7-7183-c36a-e063-6394a90ad9801fb2e6a7-7182-c36a-e063-6394a90ad9802024-08-15WarningsExact identifier
spl id: 1fb2e6a7-7183-c36a-e063-6394a90ad980
spl set id: 1fb2e6a7-7182-c36a-e063-6394a90ad980

Reported adverse events (FAERS/openFDA)#

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