FDA.reportPublic FDA data

FAK Care4 Bus and School Yellow ORM D

Manufacturer
GFA Production (Xiamen) Co., Ltd. | Lights Medical Manufacture Co., Ltd.
Effective date
2025-01-22
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 00:53:23

Label at a glance#

ProductFAK Care4 Bus and School Yellow ORM D
Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL
Label structure33 sections

Indications and uses

First aid to help prevent infection in minor cuts, scrapes, and burns. For the temporary relief of pain and itching associated with minor burns, minor cuts, and scrapes.

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 to 3 times daily. • May be covered with a sterile bandage.

Label contents#

Full prescribing information#

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin zinc (bacitracin 400 units)

Neomycin sulfate (neomycin 3.5 mg)

Polymyxin B sulfate (polymyxin B 5,000 units)

Purpose

OTC - PURPOSE SECTION

First aid antibiotic

Use

INDICATIONS & USAGE SECTION

  • First aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

• 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

OTC - ASK DOCTOR SECTION

• deep or puncture wounds • animal bites • serious burns.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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 right away.

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 to 3 times daily. • May be covered with a sterile bandage.

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, petrolatum, purified water

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Lidocaine hydrochloride 0.5

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Pain relieving cream

Uses

INDICATIONS & USAGE SECTION

  • First aid to help prevent infection in minor cuts, scrapes, and burns.
  • For the temporary relief of pain and itching associated with minor burns, minor cuts, and scrapes.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

• in the eyes • over large areas of the body • in large quantities • over raw surfaces or blistered areas • longer than 1 week unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• deep or puncture wounds • animal bites • serious burns.

Stop use and ask a doctor if

OTC - STOP USE SECTION

• the condition persists or gets worse • symptoms persist for more than 7 days or clear up and occur again within a few days

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area
  • Adults and children 2 years of age and older: Apply a small amount of this product to affected area not more than 3 times daily
  • Children under 2 years of age: consult a doctor
  • May be covered with a sterile bandage

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin monostearate, glycerol, purified water

Active ingredient:

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol, 70% v/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use:

INDICATIONS & USAGE SECTION

For preparation of the skin before injection.

Warnings:

WARNINGS SECTION

For external use only.

Flammable: keep away from fire or flame.

Do not use:

OTC - DO NOT USE SECTION

with electrocautery, in the eyes

Stop use

OTC - STOP USE SECTION

if irritation and redness develop. if condition persists for more than 72 hours, consult your doctor.

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 right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Wipe injection site vigorously and discard.

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature 15°-30° C (59°-86° F)

Inactive ingredient:

INACTIVE INGREDIENT SECTION

Purified water.

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Purpose:

OTC - PURPOSE SECTION

First Aid Antiseptic

Use:

INDICATIONS & USAGE SECTION

For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.

Warnings:

WARNINGS SECTION

For external use only.

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 right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

Do not use:

OTC - DO NOT USE SECTION

In the eyes, or over large areas of the body.

Directions:

DOSAGE & ADMINISTRATION SECTION

Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.

Inactive ingredient:

INACTIVE INGREDIENT SECTION

Purified water.

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzocaine, 6% w/v

SD alcohol,  60% w/v

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic Antiseptic

Use:

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

Warnings:

WARNINGS SECTION

For external use only.

Do not use:

OTC - DO NOT USE SECTION

In eyes, on broken skin, deep puncture wounds. If unusual redness,swelling, irritation or other symptoms occur, consult a physician immediately.

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 right away.

Flammable - keep away from fire or flame. Avoid contact with eyes. If this happens, rinse thoroughly with water.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Purified water.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KitKitKit2Kit2

First Aid Antibiotic Ointment, 0.9g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid AntibioticFirst Aid Antibiotic

First Aid Antiseptic Pain Relieving Cream, 0.9g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Antiseptic PainFirst Aid Antiseptic Pain

Alcohol Cleansing Pad

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Alcohol Cleansing PadAlcohol Cleansing Pad

Antiseptic Towelette

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antiseptic ToweletteAntiseptic Towelette

Insect Sting Relief Pad

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Insect Sting Relief PadInsect Sting Relief Pad

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204602bacitracin 400 UNT / neomycin 3.5 MG / polymyxin B 5000 UNT per GM Topical OintmentPSN7
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN7
1038558benzalkonium chloride 0.13 % Medicated PadPSN7
1046313benzocaine 6 % / ethanol 60 % Medicated PadPSN7
797544isopropyl alcohol 70 % Medicated PadPSN7
204602bacitracin 0.4 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 5 UNT/MG Topical OintmentSCD7
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD7
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD7
1046313benzocaine 60 MG/ML / ethanol 0.6 ML/ML Medicated PadSCD7
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD7
204602bacitracin 400 UNT / neomycin 3.5 MG (as neomycin sulfate 5 MG) / polymyxin B 5000 UNT per GM Topical OintmentSY7
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY7
1038558benzalkonium chloride 0.13 % Topical ClothSY7
1038558benzalkonium chloride 0.13 % Topical SwabSY7
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY7
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY7
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY7
1046313benzocaine 6 % / ethanol 60 % Topical SwabSY7
797544isopropyl alcohol 70 % Medicated PadSY7
797544isopropyl alcohol 70 % Topical ClothSY7
797544isopropyl alcohol 70 % Topical SwabSY7

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
BENZOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50814-002-01FAK Care4 Bus and School Yellow ORM D0.45 g in 1 POUCHSWAB0.45 g0.13 g in 100g7
50814-002-01FAK Care4 Bus and School Yellow ORM D1 in 1 BOXSWAB0.13 g in 100g7
50814-009-01FAK Care4 Bus and School Yellow ORM D0.9 g in 1 PACKAGECREAM0.9 g1.3 mg in 1g7
50814-039-01FAK Care4 Bus and School Yellow ORM D1 in 1 BOXSWAB700 mg in 1g7
50814-039-01FAK Care4 Bus and School Yellow ORM D0.45 g in 1 BAGSWAB0.45 g700 mg in 1g7
50814-041-02FAK Care4 Bus and School Yellow ORM D0.53 mL in 1 POUCHSWAB0.53 mL600 mg in 1mL7
50814-042-01FAK Care4 Bus and School Yellow ORM D1 in 1 KITKIT17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50814-002FAK CARE4 BUS AND SCHOOL YELLOW ORM D (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]7Legacy NDC20250123_3b5d07c6-bda2-4bc7-89b8-88280d11ed74.zip
50814-007FAK CARE4 BUS AND SCHOOL YELLOW ORM D (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]7Legacy NDC20250123_3b5d07c6-bda2-4bc7-89b8-88280d11ed74.zip
50814-009FAK CARE4 BUS AND SCHOOL YELLOW ORM D (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]7Legacy NDC20250123_3b5d07c6-bda2-4bc7-89b8-88280d11ed74.zip
50814-039FAK CARE4 BUS AND SCHOOL YELLOW ORM D (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]7Legacy NDC20250123_3b5d07c6-bda2-4bc7-89b8-88280d11ed74.zip
50814-041FAK CARE4 BUS AND SCHOOL YELLOW ORM D (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]7Legacy NDC20250123_3b5d07c6-bda2-4bc7-89b8-88280d11ed74.zip
50814-042FAK CARE4 BUS AND SCHOOL YELLOW ORM D (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOL) KIT [GFA PRODUCTION (XIAMEN) CO., LTD.]7Current NDC, Legacy NDC, 7 package rows20250123_3b5d07c6-bda2-4bc7-89b8-88280d11ed74.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50814-00750814-007-01
50814-00950814-009-01
50814-03950814-039-01
50814-04250814-042-01
50814-00250814-002-01
50814-04150814-041-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
WATER059QF0KO0RIACT
BACITRACIN ZINC89Y4M234ESACTIM
NEOMYCIN SULFATE057Y626693ACTIM
POLYMYXIN B SULFATE19371312D4ACTIM
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB
WATER059QF0KO0RIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
WATER059QF0KO0RIACT
BENZOCAINEU3RSY48JW5ACTIB
ALCOHOL3K9958V90MACTIB

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N000004-004PAREDRINEHYDROXYAMPHETAMINE HYDROBROMIDE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982c2088c7a36db…
2026-09-14 22:38:342026-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N000004-004PAREDRINE1%SOLUTION/DROPS / OPHTHALMICApproved before 19823a93d1ddd44b…

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
FAK Care4 Bus and School Yellow ORM DBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, BENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE, ISOPROPYL ALCOHOL, BENZOCAINE, ALCOHOLGFA Production (Xiamen) Co., Ltd.3b5d07c6-bda2-4bc7-89b8-88280d11ed742025-01-22WarningsExact identifier
ndc (package): 50814-007-01
ndc (package): 50814-041-02
ndc (package): 50814-042-01
ndc (package): 50814-002-01
ndc (package): 50814-009-01
ndc (package): 50814-039-01
ndc (product): 50814-042
ndc11 (package): 50814000201
ndc11 (package): 50814004201
ndc11 (package): 50814004102
ndc11 (package): 50814000701
ndc11 (package): 50814003901
ndc11 (package): 50814000901
spl id: 2c4cbe6c-c27a-15fe-e063-6294a90ac409
spl set id: 3b5d07c6-bda2-4bc7-89b8-88280d11ed74

Reported adverse events (FAERS/openFDA)#

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