FDA.reportPublic FDA data

Fonow

Manufacturer
Zhejiang Fonow Medicine Co., Ltd.
Effective date
2025-02-21
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 20:41:05

Label at a glance#

ProductFonow
Active ingredientBACITRACIN, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE
Label structure10 sections

Indications and uses

Fist aid to help prevent infection and provide temporary relief of pain and itching in minor cuts scrapes burns

Dosage and administration

Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 or 3 times daily. May be covered with a sterile bandage.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin 500 units

Neomycin 3.5mg

Polymyxin B 5000 units

Lidocaine HCl 40 mg

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

First aid antibiotic

First aid antibiotic

Anesthetic

Uses

INDICATIONS & USAGE SECTION

Fist aid to help prevent infection and provide temporary relief of pain and itching in

  • minor cuts
  • scrapes
  • burns

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 or 3 times daily. May be covered with a sterile bandage.

Warnings

WARNINGS SECTION

For external use only.

Do not use

  • in the eyes
  • over large areas of the body
  • if you are allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

  • the condition persists or gets worse
  • a rash or other allergic reaction occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Other information

SPL UNCLASSIFIED SECTION

Store at temperature 50°F-86°F (10℃-30℃)

Inactive ingredient

INACTIVE INGREDIENT SECTION

White Petrolatum

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts
Active ingredients (in each gram)........................................... Purpose
Bacitracin 500 units ......................................................First aid antibiotic
Neomycin 3.5mg ............................................................First aid antibiotic
Polymyxin B 5000 units..................................................First aid antibiotic
Lidocaine Hcl 40 mg........................ .... .... ... .......................... Anesthetic

Uses

First aid to help prevent infection and provide temporary relief of pain in minor cuts scrapes burns

Warnings
For external use only.
Do not use

  • in the eyes
  • over large ares of the body
  • if allergic to any of the ingredients
  • longer than 1 week unless directed by a doctor


Ask a doctor before use if you have

  • deep or puncture wounds
  • animal bites
  • serious burns


Stop use and ask a doctor if

  • condition persists or gets worse
  • a rash or other allergic reaction occurs


Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions
Clean the affected area. Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 or 3 times daily. May be covered with a sterile bandage.

Other information

Store at temperature 50°-86℉(10°-30℃)

Inactive ingredient

White Petrolatum

52454-001-04 label52454-001-04 label

52454-001-03 label52454-001-03 label

52454-001-02 outer package52454-001-02 outer package

52454-001-02 inner package52454-001-02 inner package

52454-001-01 label52454-001-01 label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52454-001-012023-06-29C16284748780-19d75b9d0-9c2e-f424-e053-dadaa90a57ce74057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-022023-06-29C16284748780-19d75b9d0-9c2e-f424-e053-dadaa90a57ce74057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-032023-06-29C16284748780-19d75b9d0-9c2e-f424-e053-dadaa90a57ce74057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-012023-01-30C16284748780-19d75b9d0-9c2e-f424-e053-dadaa90a57ce74057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-022023-01-30C16284748780-19d75b9d0-9c2e-f424-e053-dadaa90a57ce74057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-032023-01-30C16284748780-19d75b9d0-9c2e-f424-e053-dadaa90a57ce74057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-012020-02-28C16284748780-19d75b9d0-9c2e-f424-e053-dadaa90a57ce74057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-022020-02-28C16284748780-19d75b9d0-9c2e-f424-e053-dadaa90a57ce74057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-012020-01-31C16284748780-19d75b9d0-9c2e-f424-e053-dadaa90a57ce74057ff8-d4c9-4e7d-84f9-c34b2d793e5f
52454-001-022020-01-31C16284748780-19d75b9d0-9c2e-f424-e053-dadaa90a57ce74057ff8-d4c9-4e7d-84f9-c34b2d793e5f

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52454-001FONOW (BACITRACIN, NEOMYCIN, POLYMYXIN B, LIDOCAINE HCL) OINTMENT [ZHEJIANG FONOW MEDICINE CO., LTD.]11Legacy NDC20250224_74057ff8-d4c9-4e7d-84f9-c34b2d793e5f.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52454-00152454-001-01, 52454-001-02, 52454-001-03, 52454-001-04

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
WHITE PETROLATUMB6E5W8RQJ4IACT
BACITRACIN58H6RWO52IACTIB
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
LIDOCAINE98PI200987ACTIB

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
36a7389c-51f7-833a-e063-6294a90a3a0c74057ff8-d4c9-4e7d-84f9-c34b2d793e5f2025-06-03WarningsExact identifier
spl set id: 74057ff8-d4c9-4e7d-84f9-c34b2d793e5f

Reported adverse events (FAERS/openFDA)#

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