Safe OPA

Manufacturer: Valley Inc.
Effective date: 2024-12-09
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 00:41:28

Label at a glance#

ProductSafe OPA

Active ingredientO-PHTHALALDEHYDE

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

O-PHTHALALDEHYDE 0.55%

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Monopotassium phosphate, Dipotassium hydrogen phosphate

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 carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
81803-030-02	2026-01-29	C162847	48780-1	49896155-a7bc-586f-e063-e6dba90add90	89393417-c8a3-46bf-ad89-db7b8c360c85
81803-030-02	2026-01-29	C162847	48780-1	49896155-a7bc-586f-e063-e6dba90add90	89393417-c8a3-46bf-ad89-db7b8c360c85

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81803-030-01	Safe OPA	4000 mL in 1 BOTTLE	LIQUID	4000		4
81803-030-02	Safe OPA	1 in 1 CARTON	LIQUID	1		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81803-030	SAFE OPA (O-PHTHALALDEHYDE) LIQUID [VALLEY INC.]	4	Legacy NDC, 2 package rows	20241210_89393417-c8a3-46bf-ad89-db7b8c360c85.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

Safe OPA
O-PHTHALALDEHYDE
WATER
MONOBASIC POTASSIUM PHOSPHATE
DIBASIC POTASSIUM PHOSPHATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
81803-030	81803-030-01, 81803-030-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
MONOBASIC POTASSIUM PHOSPHATE	4J9FJ0HL51	IACT
DIBASIC POTASSIUM PHOSPHATE	CI71S98N1Z	IACT
O-PHTHALALDEHYDE	4P8QP9768A	ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
1	2022-06-08	full-release	2026-05-31 23:49:48

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
28d2e632-6526-b422-e063-6394a90a4f1a			89393417-c8a3-46bf-ad89-db7b8c360c85	2024-12-09	Warnings	Exact identifier spl id: 28d2e632-6526-b422-e063-6394a90a4f1a spl set id: 89393417-c8a3-46bf-ad89-db7b8c360c85

Reported adverse events (FAERS/openFDA)#

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