FDA.reportPublic FDA data

Cygzyme plus

Manufacturer
Valley Inc.
Effective date
2024-12-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:41:27

Label at a glance#

ProductCygzyme plus
Active ingredientPERACETIC ACID
Label structure9 sections

Indications and uses

Helps prevent sterilant

Dosage and administration

■ Rinse thoroughly for more than 5 minutes. Rinse for more than 15 seconds with sterile purified water flowing out after soaking. ■ After the disinfection of the medical instrument is completed, confirm the persistence. ■ Excess water may be used depending on the purpose of use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Peracetic acid 0.05%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Lauramine oxide, Sodium bicarbonate, Sodium acetate, anhydrous, Subtilisins, Cellulase, Rizolipase, alpha Amylase, Brilliant Blue, Alcohols, C12-14, ethoxylated, propoxylated, Sodium sesquicarbonate

PURPOSE

OTC - PURPOSE SECTION

Antifungal

WARNINGS

WARNINGS SECTION

■ For external use only
■ Do not use on the human body
■ Avoid contact with eyes.
■ Discontinue use if signs of irritation or rashes appear.
■ Keep out of reach of children.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Uses

INDICATIONS & USAGE SECTION

Helps prevent sterilant

Directions

DOSAGE & ADMINISTRATION SECTION

■ Rinse thoroughly for more than 5 minutes. Rinse for more than 15 seconds with sterile purified water flowing out after soaking.
■ After the disinfection of the medical instrument is completed, confirm the persistence.
■ Excess water may be used depending on the purpose of use.

QUESTIONS

OTC - QUESTIONS SECTION

+82 02 1566 2723

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81803-050-01Cygzyme plus4000 mL in 1 BOTTLELIQUID40002
81803-050-02Cygzyme plus1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81803-050CYGZYME PLUS (PERACETIC ACID) LIQUID [VALLEY INC.]22 package rows20241210_54de3773-3fc2-42c4-8212-ef704f64a706.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
81803-05081803-050-01, 81803-050-02

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
LAURAMINE OXIDE4F6FC4MI8WIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM ACETATE4550K0SC9BIACT
PERACETIC ACIDI6KPI2E1HDACTIB

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
28d2ba88-022a-390c-e063-6294a90a0bcf54de3773-3fc2-42c4-8212-ef704f64a7062024-12-09WarningsExact identifier
spl id: 28d2ba88-022a-390c-e063-6294a90a0bcf
spl set id: 54de3773-3fc2-42c4-8212-ef704f64a706

Reported adverse events (FAERS/openFDA)#

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