FDA.reportPublic FDA data

Tree frog

Manufacturer
Laboratorios Zepol S.A.
Effective date
2023-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:24:58

Label at a glance#

ProductTree frog
Active ingredientCOMFREY ROOT, ROSEMARY
Label structure4 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Directions:

OTC - PURPOSE SECTION

For minor aches and pains

DOSAGE & ADMINISTRATION SECTION

External use only. For best results, apply two to three times daily as needed.

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Protect from heat, light and moisture. Do not use if safety seal is broken or missing. Do not use with a heating pad. Do not apply to cut, irritated or demaged skin. Do not use on face or near eyes.

Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Symphytum officinale extract 10X,

Rosmarinus officinale extract 1X.

Other ingredients:

INACTIVE INGREDIENT SECTION

Water, Carbomer, Phenoxyethanol (and) Caprylyl Glycol (and) Decylene Glycol, Eucalyptus globulus leaf oil, Gliceryn, Polysorbate 20, Color, Alcohol, Camphor, Menthol, Triethanolamine, Cinnamon aroma.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55715-006-01Tree frog8 g in 1 PACKETGEL82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55715-006TREE FROG (COMFREY ROOT, ROSEMARY) GEL [LABORATORIOS ZEPOL S.A.]2Current NDC, 1 package rows20231202_fc98fc89-8f7c-cbda-e053-6394a90a4254.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55715-00655715-006-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
ALCOHOL3K9958V90MIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
TROLAMINE9O3K93S3TKIACT
POLYSORBATE 207T1F30V5YHIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CINNAMON5S29HWU6QBIACT
DECYLENE GLYCOLS57M60MI88IACT
COMFREY ROOTM9VVZ08EKQACTIB
ROSEMARYIJ67X351P9ACTIB

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
Tree frogCOMFREY ROOT, ROSEMARYLaboratorios Zepol S.A.fc98fc89-8f7c-cbda-e053-6394a90a42542023-12-01WarningsExact identifier
ndc (package): 55715-006-01
ndc (product): 55715-006
ndc11 (package): 55715000601
spl id: 0b764e6c-d79d-bffa-e063-6294a90a98c0
spl set id: fc98fc89-8f7c-cbda-e053-6394a90a4254

Reported adverse events (FAERS/openFDA)#

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