FDA.reportPublic FDA data

87742-001

Manufacturer
Guangxi Rise Biological Technology Co.,Ltd.
Effective date
2026-06-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-06-18 05:10:14

Label at a glance#

ProductBIOSHUGA Dermomucosal Antibacterial Gel
Active ingredientLYSOZYME
Label structure11 sections

Dosage and administration

Apply an appropriate amount to the affected area Leave on for at least2 minutes

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Lysozyme (18,000-22,000 U/mL)

Purpose

OTC - PURPOSE SECTION

Antibacterial agent

Use

INDICATIONS & USAGE SECTION

Helps reduce bacteria on intact skin and mucosal surfaces
Provides antibacterial protection for external use

Warnings

WARNINGS SECTION

For external use only
Not a drug product; does not treat, cure, or prevent disease
When used on vaginal mucosa, it should not be used for prevention of sexually transmitted diseases

Do not use

OTC - DO NOT USE SECTION

Do not use if you are allergic to any of the ingredients

OTC - WHEN USING SECTION

When using this product do not get into eyes,
If contact occurs, rinse thoroughly with water;
Avoid using with incompatible (antagonistic) medications

OTC - STOP USE SECTION

lf an allergic reaction occurs, stop use immediately and consult a doctor.

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

Apply an appropriate amount to the affected area
Leave on for at least2 minutes

Inactive ingredients

INACTIVE INGREDIENT SECTION

Disodium EDTA,Glycerin,Hydroxyethyl cellulose,
Purified water,Sodium acetate,Sorbitol

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

undefinedundefined

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87742-00187742-001-01, 87742-001-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
HYDROXYETHYLCELLULOSET4V6TWG28DIACT
SODIUM ACETATE4550K0SC9BIACT
WATER059QF0KO0RIACT
EDETATE DISODIUM7FLD91C86KIACT
LYSOZYME968JKA7T33ACTIB

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
BIOSHUGA Dermomucosal Antibacterial GelBIOSHUGA DERMOMUCOSAL ANTIBACTERIAL GELGuangxi Rise Biological Technology Co.,Ltd.5456574a-dda4-9c67-e063-6294a90ac2222026-06-15WarningsExact identifier
ndc (package): 87742-001-02
ndc (package): 87742-001-01
ndc (product): 87742-001
ndc11 (package): 87742000102
ndc11 (package): 87742000101
spl id: 545659b0-251d-9745-e063-6294a90aa64d
spl set id: 5456574a-dda4-9c67-e063-6294a90ac222

Reported adverse events (FAERS/openFDA)#

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