TREE FROG- comfrey root, rosemary gel
Laboratorios Zepol S.A.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

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Tree frog

Symphytum officinale extract 10X,

Rosmarinus officinale extract 1X.

For Purpose of

Pain Relief

Other ingredients:

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

Directions:

For minor aches and pains. External use only.

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

WARNINGS SECTION

Keep out of reach of children.

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 damaged skin. Do not use on face or near eyes.

Package Labeling:

Label

TREE FROG
comfrey root, rosemary gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55715-007
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ)	COMFREY ROOT	10 [hp_X] in 1 mL
ROSEMARY (UNII: IJ67X351P9) (ROSEMARY - UNII:IJ67X351P9)	ROSEMARY	1 [hp_X] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
ALCOHOL (UNII: 3K9958V90M)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
TROLAMINE (UNII: 9O3K93S3TK)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CINNAMON (UNII: 5S29HWU6QB)
DECYLENE GLYCOL (UNII: S57M60MI88)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55715-007-01	120 mL in 1 CONTAINER; Type 0: Not a Combination Product	05/16/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		05/16/2023

Labeler - Laboratorios Zepol S.A. (853070985)

Revised: 5/2023

Document Id: fbf823cc-f8d6-44c7-e053-6394a90a9cc6

Set id: 76d1a912-c7a8-43b8-b242-fbbd54f1de01

Version: 1

Effective Time: 20230518

Laboratorios Zepol S.A.