FDA.reportPublic FDA data

GUNA-TGF BETA 1

Manufacturer
Guna spa
Effective date
2022-11-15
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:18:32

Label at a glance#

ProductGUNA-TGF BETA 1
Active ingredientTRANSFORMING GROWTH FACTOR BETA-1
Label structure8 sections

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      5 drops twice a day in a glass of water.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

TRANSFORMING GROWTH FACTOR BETA-1     4C

PURPOSE

OTC - PURPOSE SECTION

Anti-inflammatory

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medicines out of reach of children

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

Anti-inflammatory

WARNINGS

WARNINGS SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION 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     5 drops twice a day in a glass of water.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Ethyl Alcohol 30%

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of box labelimage of box label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17089-395-182020-03-13C16284748780-19d75b9d0-1cd5-f424-e053-dadaa90a57ceGUNA-TGF BETA 1
17089-395-182020-01-31C16284748780-19d75b9d0-1cd5-f424-e053-dadaa90a57ceGUNA-TGF BETA 1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-395-18GUNA-TGF BETA 11 in 1 BOXSOLUTION/ DROPS15
17089-395-18GUNA-TGF BETA 130 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-395GUNA-TGF BETA 1 (TRANSFORMING GROWTH FACTOR BETA 1) SOLUTION/ DROPS [GUNA SPA]5Current NDC, Legacy NDC, 2 package rows20221116_15162e09-435e-4ff7-8dba-ffd92fd58a3f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TRANSFORMING GROWTH FACTOR BETA-1ACTIVE INGREDIENTT7D25J14LT1
TRANSFORMING GROWTH FACTOR BETA-1ACTIVE MOIETYT7D25J14LT1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1

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
17089-39517089-395-18

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
TRANSFORMING GROWTH FACTOR BETA-1T7D25J14LTACTIB

Source Document#

Source XML

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
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact 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
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 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
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact 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
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact 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
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 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-TGF BETA 1TRANSFORMING GROWTH FACTOR BETA 1Guna spa15162e09-435e-4ff7-8dba-ffd92fd58a3f2022-11-15WarningsExact identifier
ndc (package): 17089-395-18
ndc (product): 17089-395
ndc11 (package): 17089039518
spl id: ed85374b-6458-049e-e053-2995a90a99df
spl set id: 15162e09-435e-4ff7-8dba-ffd92fd58a3f

Reported adverse events (FAERS/openFDA)#

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