Label: FIBROCANE RELIEF- symphytum officinale, capsicum annuum, ledum palustre, colchicum autumnale, rhododendron chrysanthum, ruta graveolens, gel
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Contains inactivated NDC Code(s)
NDC Code(s): 57850-2000-1 - Packager: Premier Bioceuticals LLC
- Category: HUMAN OTC DRUG LABEL
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 June 23, 2014
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- ACTIVE INGREDIENTS:
- INDICATIONS:
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WARNINGS:
For external use only.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
When using this product do not get into eyes.
Stop use and call a doctor if condition worsens or symptoms last more than 7 days.
Consult a physician for use in children under 12 years of age.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
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INACTIVE INGREDIENTS:
Acrylates/C10-30 alkyl acrylate crosspolymer, Aloe barbadensis leaf juice, Arnica (flower), Ascorbic acid, Celery (seed), Comfrey leaf, Devil's Claw (root), Edate disodium (EDTA), Feverfew (leaf), Vitamin E, Oregano, PEG-33, PEG-8 Dimethicone, PEG-14, Phenoxyethanol, Capryly glycol, Sorbic acid, Poke (root), Potassium sorbate, Purified Water, Sodium hydroxide, Turmeric (root), White willow (bark)
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
FIBROCANE RELIEF
symphytum officinale, capsicum annuum, ledum palustre, colchicum autumnale, rhododendron chrysanthum, ruta graveolens, gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:57850-2000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COMFREY ROOT (UNII: M9VVZ08EKQ) (COMFREY ROOT - UNII:M9VVZ08EKQ) COMFREY ROOT 3 [hp_X] in 1 g CAPSICUM (UNII: 00UK7646FG) (CAPSICUM - UNII:00UK7646FG) CAPSICUM 6 [hp_X] in 1 g LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG 6 [hp_X] in 1 g COLCHICUM AUTUMNALE BULB (UNII: 993QHL78E6) (COLCHICUM AUTUMNALE BULB - UNII:993QHL78E6) COLCHICUM AUTUMNALE BULB 12 [hp_X] in 1 g RHODODENDRON AUREUM LEAF (UNII: IV92NQJ73U) (RHODODENDRON AUREUM LEAF - UNII:IV92NQJ73U) RHODODENDRON AUREUM LEAF 12 [hp_X] in 1 g RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP 12 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) ASCORBIC ACID (UNII: PQ6CK8PD0R) CELERY SEED (UNII: 1G1EAA320L) COMFREY LEAF (UNII: DG4F8T839X) HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89) EDETATE DISODIUM (UNII: 7FLD91C86K) FEVERFEW (UNII: Z64FK7P217) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) OREGANO (UNII: 0E5AT8T16U) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) PEG-8 DIMETHICONE (UNII: GIA7T764OD) POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) TURMERIC (UNII: 856YO1Z64F) SALIX ALBA BARK (UNII: 205MXS71H7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:57850-2000-1 57 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/17/2014 Labeler - Premier Bioceuticals LLC (027714978) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(57850-2000) , api manufacture(57850-2000) , label(57850-2000) , pack(57850-2000)