Label: PHYTOGEL- homeopathic gel gel
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Contains inactivated NDC Code(s)
NDC Code(s): 64578-0110-1 - Packager: Energetix Corp
- 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 February 25, 2014
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- PRINCIPAL DISPLAY PANEL
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Active Ingredients
Arnica montana 1X–0.54%, Calendula officinalis 1X–0.54%, Hypericum perforatum 1X–0.54%, Arnica montana 30C, Bellis perennis 12X, Calcarea fluorica 30X, Ferrum phosphoricum 30X, Hypericum perforatum 30C, Ledum palustre 12X, Natrum sulphuricum 30C, Rhus toxicodendron 30X, Sulphuricum acidum 12X, Symphytum officinale 3X
- Warnings Section
- DO NOT USE
- OVERDOSAGE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- STORAGE AND HANDLING
- QUESTIONS
- PURPOSE
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
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INGREDIENTS AND APPEARANCE
PHYTOGEL
homeopathic gel gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64578-0110 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 1 [hp_X] in 59.1 mL BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS 12 [hp_X] in 59.1 mL CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE 30 [hp_X] in 59.1 mL CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 1 [hp_X] in 59.1 mL FERRUM PHOSPHORICUM (UNII: 91GQH8I5F7) (FERROSOFERRIC PHOSPHATE - UNII:91GQH8I5F7) FERRUM PHOSPHORICUM 30 [hp_X] in 59.1 mL HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM 1 [hp_X] in 59.1 mL LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 12 [hp_X] in 59.1 mL SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 30 [hp_C] in 59.1 mL TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 30 [hp_X] in 59.1 mL SULFURIC ACID (UNII: O40UQP6WCF) (SULFURIC ACID - UNII:O40UQP6WCF) SULFURIC ACID 12 [hp_X] in 59.1 mL COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 3 [hp_X] in 59.1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 7.395801 mL in 59.1 mL ALCOHOL (UNII: 3K9958V90M) 1.84895 mL in 59.1 mL ALOE (UNII: V5VD430YW9) 46.494 g in 59.1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64578-0110-1 59.1 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/14/2014 Labeler - Energetix Corp (969572502) Establishment Name Address ID/FEI Business Operations Terra Botanica LLC 963736785 manufacture(64578-0110) , label(64578-0110) , pack(64578-0110)