FDA.reportPublic FDA data

GUNA-DERMO

Manufacturer
Guna spa
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:10:42

Label at a glance#

ProductGUNA-DERMO
Active ingredientALDESLEUKIN, ARSENIC TRIOXIDE, ATROPA BELLADONNA, CANAKINUMAB, ECHINACEA ANGUSTIFOLIA, GRAPHITE, MELATONIN, PLANTAGO MAJOR, SOLANUM DULCAMARA FLOWER, SULFUR
Label structure10 sections

Indications and uses

Temporary relief of symptoms of general skin irritation and rashes such as: Itching Dryness Hypersensitivity

Dosage and administration

Adults and children 12 years and older 20 drops in a little water, 2 times per day Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day Children under 6 years 5 drops in a glass of water, 2 times per day

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS/PURPOSE

OTC - ACTIVE INGREDIENT SECTION

ARSENICUM ALBUM        6C    SKIN BLISTERS
BELLADONNA        6C    SWELLING
DULCAMARA        6C    MUSCLE SORENESS
ECHINACEA ANGUSTIFOLIA    6C    ANTI-INFECTION
GRAPHITES        6C    SKIN INFLAMMATION
INTERLEUKIN 1 BETA    7C    IMMUNE STRENGTHENING
INTERLEUKIN 2        4C    IMMUNE STRENGTHENING
MELATONIN        4C    HORMONAL SUPPORT
PLANTAGO MAJOR        4C    DETOXIFICATION
SULPHUR            6C    SENSITIVE SKIN

USES

OTC - PURPOSE SECTION

Temporary relief of symptoms of general skin irritation and rashes such as:

  • Itching
  • Dryness
  • Hypersensitivity

WARNINGS

WARNINGS SECTION

Stop use and ask doctor if symptoms persist more than 5 days.
If pregnant or breast-feeding ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Contains ethyl alcohol 30%

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

DOSAGE & ADMINISTRATION SECTION



Adults and children 12 years and older 20 drops in a little water, 2 times per day

Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day

Children under 6 years 5 drops in a glass of water, 2 times per day

QUESTIONS

OTC - QUESTIONS SECTION

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

INDICATIONS & USAGE SECTION

Take 15 minutes before meals

INACTIVE INGREDIENT SECTION

Inactive ingredient. Ethyl alcohol 30%.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

5USDER-Rev02-21-05-185USDER-Rev02-21-05-18

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
bd1801bf-1b8e-49c6-894d-a4af5821c1abProduct name120161129

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17089-295-18GUNA-DERMO30 mL in 1 BOTTLE, DROPPERSOLUTION/ DROPS302
17089-295-18GUNA-DERMO1 in 1 BOXSOLUTION/ DROPS12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17089-295GUNA-DERMO (ALDESLEUKIN - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CANAKINUMAB - ECHINACEA ANGUSTIFOLIA - GRAPHITE - MELATONIN - PLANTAGO MAJOR - SOLANUM DULCAMARA FLOWER - SULFUR -) SOLUTION/ DROPS [GUNA SPA]2Current NDC, Legacy NDC, 2 package rows20190104_8bf717eb-fe46-4066-b124-eb715ffc1542.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALDESLEUKINACTIVE INGREDIENTM89N0Q7EQR1
ARSENIC TRIOXIDEACTIVE INGREDIENTS7V92P67HO1
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
CANAKINUMABACTIVE INGREDIENT37CQ2C7X931
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US81
GRAPHITEACTIVE INGREDIENT4QQN74LH4O1
MELATONINACTIVE INGREDIENTJL5DK93RCL1
PLANTAGO MAJORACTIVE INGREDIENTW2469WNO6U1
SOLANUM DULCAMARA FLOWERACTIVE INGREDIENTW6J1279A6K1
SULFURACTIVE INGREDIENT70FD1KFU701
ALDESLEUKINACTIVE MOIETYM89N0Q7EQR1
ARSENIC TRIOXIDEACTIVE MOIETYS7V92P67HO1
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
CANAKINUMABACTIVE MOIETY37CQ2C7X931
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US81
GRAPHITEACTIVE MOIETY4QQN74LH4O1
MELATONINACTIVE MOIETYJL5DK93RCL1
PLANTAGO MAJORACTIVE MOIETYW2469WNO6U1
SOLANUM DULCAMARA FLOWERACTIVE MOIETYW6J1279A6K1
SULFURACTIVE MOIETY70FD1KFU701
ALCOHOLINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
17089-29517089-295-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
ALDESLEUKINM89N0Q7EQRACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CANAKINUMAB37CQ2C7X93ACTIB
ECHINACEA ANGUSTIFOLIAVB06AV5US8ACTIB
GRAPHITE4QQN74LH4OACTIB
MELATONINJL5DK93RCLACTIB
PLANTAGO MAJORW2469WNO6UACTIB
SOLANUM DULCAMARA FLOWERW6J1279A6KACTIB
SULFUR70FD1KFU70ACTIB

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
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 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
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact 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
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route
22 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact 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-DERMOALDESLEUKIN - ARSENIC TRIOXIDE - ATROPA BELLADONNA - CANAKINUMAB - ECHINACEA ANGUSTIFOLIA - GRAPHITE - MELATONIN - PLANTAGO MAJOR - SOLANUM DULCAMARA FLOWER - SULFUR -Guna spa8bf717eb-fe46-4066-b124-eb715ffc15422018-12-21WarningsExact identifier
ndc (package): 17089-295-18
ndc (product): 17089-295
ndc11 (package): 17089029518
spl id: 7e8f7213-7f6e-14ab-e053-2991aa0a4669
spl set id: 8bf717eb-fe46-4066-b124-eb715ffc1542

Reported adverse events (FAERS/openFDA)#

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