SPL v2
SPL
SPL Set ID a2a1ecde-fecf-3744-e053-2a95a90a4251
Route
EXTRACORPOREAL
Published
Effective Date 2020-04-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Benzalkonium (0.072 mg)
Inactive Ingredients
Propylene Glycol Sodium Phosphate, Monobasic, Dihydrate Sodium Phosphate Dibasic Dihydrate Water Edetate Disodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
UNAPPROVED DRUG OTHER Active Since 2020-04-06

Description

benzalkonium chloride


Medication Information

Warnings and Precautions

1.This product is one kind of solution for external use, and is never for internal usage.

2.Activity of this product may be affected by anion surfactant or soap, and cannot be used together.

3.It is forbidden for people who are allergic to this product.

4.Turbidity or deposits may appear at a low temperature. It can be placed in warm waterfor heating, or used after it is dissolved through shaking.

5.It shall be sealed and kept in a dark and dry place.

6.Mucosa disinfection is only used for diagnosis and treatment by a medical institution.

Indications and Usage

It shall be directly sprayed onto skin, wounds, mucosa and infected parts. It can be applied several times a day to bring continuous antiseptic effects on skin surface for lasting protection.

Dosage and Administration

a little

Description

benzalkonium chloride

Section 50565-1

keep out of children

Section 51727-6

Propylene glycol

Sodium dihydrogen phosphate dihydrate

Disodium hydrogen phosphate

Disodium edetate, dihydrate

water

Section 51945-4

Section 55105-1

Kills 99.99% of germs

Section 55106-9

benzalkonium chloride


Structured Label Content

Indications and Usage (34067-9)

It shall be directly sprayed onto skin, wounds, mucosa and infected parts. It can be applied several times a day to bring continuous antiseptic effects on skin surface for lasting protection.

Dosage and Administration (34068-7)

a little

Warnings and Precautions (34071-1)

1.This product is one kind of solution for external use, and is never for internal usage.

2.Activity of this product may be affected by anion surfactant or soap, and cannot be used together.

3.It is forbidden for people who are allergic to this product.

4.Turbidity or deposits may appear at a low temperature. It can be placed in warm waterfor heating, or used after it is dissolved through shaking.

5.It shall be sealed and kept in a dark and dry place.

6.Mucosa disinfection is only used for diagnosis and treatment by a medical institution.

Section 50565-1 (50565-1)

keep out of children

Section 51727-6 (51727-6)

Propylene glycol

Sodium dihydrogen phosphate dihydrate

Disodium hydrogen phosphate

Disodium edetate, dihydrate

water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Kills 99.99% of germs

Section 55106-9 (55106-9)

benzalkonium chloride


Advanced Ingredient Data


Raw Label Data

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