FDA.reportPublic FDA data

GUNA-IL 4

Manufacturer
Guna spa
Effective date
2026-06-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
daily-update
Hydrated at
2026-06-12 05:10:08

Label at a glance#

ProductGUNA-IL 4
Active ingredientBINETRAKIN
Label structure10 sections

Indications and uses

Temporary relief of signs of inflammation

Dosage and administration

Take 15 minutes before meals. Adults and children 12 years and older 20 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow. Children between 12 years and 6 years of age 10 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow. Children under 6 years consult a physician

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

Interleukin 4   4C   Anti-inflammatory

USES

OTC - PURPOSE SECTION

Temporary relief of signs
of inflammation

WARNINGS

WARNINGS SECTION

Stop use and ask doctor if symptoms worsen or persist more than 5 days

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding ask a doctor before use

WARNINGS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of reach of children

DIRECTIONS

INDICATIONS & USAGE SECTION

Take 15 minutes before meals.



Adults and children 12 years and older 20 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow.



Children between 12 years and 6 years of age 10 drops twice a day in a little water. Hold in the mouth for about 30 seconds then swallow.



Children under 6 years consult a physician




QUESTIONS

OTC - QUESTIONS SECTION

Questions?: info@gunainc.com
Tel. (484) 223-3500

DOSAGE & ADMINISTRATION SECTION

Take 15 minutes before meals.

INACTIVE INGREDIENT SECTION

Inactive ingredient: Ethayl alcohol 30%.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5UIL45UIL4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeData Matrix5U1IL45U1IL4.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17089-382-182020-03-13C16284748780-19d75b9cf-da4b-f424-e053-dadaa90a57ceGUNA-IL 4
17089-382-182020-03-13C16284748780-19d75b9cf-da4b-f424-e053-dadaa90a57ceGUNA-IL 4
17089-382-182020-01-31C16284748780-19d75b9cf-da4b-f424-e053-dadaa90a57ceGUNA-IL 4
17089-382-182020-01-31C16284748780-19d75b9cf-da4b-f424-e053-dadaa90a57ceGUNA-IL 4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BINETRAKINACTIVE INGREDIENT751635Z9211
BINETRAKINACTIVE MOIETY751635Z9211
ALCOHOLINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-38217089-382-18

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
ALCOHOL3K9958V90MIACT
BINETRAKIN751635Z921ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52022-11-15full-release2026-06-01 02:18:34

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 22 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates

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
GUNA-IL 4BINETRAKINGuna spada1f5fe8-508d-4911-804a-8489ca97e0712026-06-10WarningsExact identifier
ndc (package): 17089-382-18
ndc (product): 17089-382
ndc11 (package): 17089038218
spl id: 53e9e686-3d18-add2-e063-6294a90ab248
spl set id: da1f5fe8-508d-4911-804a-8489ca97e071

Reported adverse events (FAERS/openFDA)#

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