SAFE OPA- o-phthalaldehyde liquid

Safe OPA by

Drug Labeling and Warnings

Safe OPA by is a Otc medication manufactured, distributed, or labeled by Valley Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

O-PHTHALALDEHYDE 0.55%

INACTIVE INGREDIENTS

Water, Monopotassium phosphate, Dipotassium hydrogen phosphate

PURPOSE

Antifungal

WARNINGS

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

Keep out of reach of children

Uses

Helps prevent sterilant

Directions

■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

+82 02 1566 2723

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SAFE OPA 
o-phthalaldehyde liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81803-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
O-PHTHALALDEHYDE (UNII: 4P8QP9768A) (O-PHTHALALDEHYDE - UNII:4P8QP9768A)	O-PHTHALALDEHYDE	22.0 g  in 4000 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
MONOBASIC POTASSIUM PHOSPHATE (UNII: 4J9FJ0HL51)
DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81803-030-02	1 in 1 CARTON	05/01/2022
1	NDC: 81803-030-01	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2022

Labeler - Valley Inc. (695095445)

Registrant - Valley Inc. (695095445)

Establishment
Name	Address	ID/FEI	Business Operations
Valley Inc.		695095445	manufacture(81803-030)