FDA.reportPublic FDA data

PHMB Disinfectant

Manufacturer
Five Hertz (Xiamen) Medical Supplies Co., Ltd.
Effective date
2023-11-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:20:31

Label at a glance#

ProductPHMB Disinfectant
Active ingredientPOLIHEXANIDE
Label structure13 sections

Dosage and administration

Suitable for the disinfection of human skin. Shake well before use, and then spray directly on the site to be disinfected - disinfecting time above 3 minutes. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

PHMB Disinfectant

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Polyhexamethylene Biguanide 0.39mg/mL. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, PHMB Disinfectant

Use

INDICATIONS & USAGE SECTION

PHMB Disinfectant to kill bacteria and virus that potentially can cause disease, and use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • Together with other disinfectants.

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Suitable for the disinfection of human skin. Shake well before use, and then spray directly on the site to be disinfected - disinfecting time above 3 minutes.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

303050508080100-100-350350

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76579-20176579-201-01, 76579-201-02, 76579-201-03, 76579-201-04, 76579-201-05, 76579-201-06, 76579-201-07, 76579-201-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLIHEXANIDE322U039GMFACTIB

Source Document#

Source XML · Source PDF

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
0a501201-92c7-432c-e063-6394a90ae69aa3efe9d2-456d-5f75-e053-2a95a90a66162023-11-16WarningsExact identifier
spl id: 0a501201-92c7-432c-e063-6394a90ae69a
spl set id: a3efe9d2-456d-5f75-e053-2a95a90a6616

Reported adverse events (FAERS/openFDA)#

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