Label: TREE FROG- comfrey root, rosemary gel
- NDC Code(s): 55715-006-01
- Packager: Laboratorios Zepol S.A.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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.
Drug Label Information
Updated December 1, 2023
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- INDICATIONS & USAGE
- Ingredients:
- Other ingredients:
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INGREDIENTS AND APPEARANCE
TREE FROG
comfrey root, rosemary gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55715-006 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 10 [hp_X] in 1 g ROSEMARY (UNII: IJ67X351P9) (ROSEMARY - UNII:IJ67X351P9) ROSEMARY 1 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55715-006-01 8 g in 1 PACKET; Type 0: Not a Combination Product 05/16/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/16/2023 Labeler - Laboratorios Zepol S.A. (853070985) Establishment Name Address ID/FEI Business Operations Laboratorios Zepol S.A. 853070985 manufacture(55715-006)