Label: ARNICA PLUS- arnica montana, hamamelis virginiana, rhus toxicodendron gel
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Contains inactivated NDC Code(s)
NDC Code(s): 43846-0021-1 - Packager: Peaceful Mountain, Inc.
- 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 March 14, 2013
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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 ask a doctor if Condition worsens Symptoms last more than 7 days.
- DIRECTIONS
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INACTIVE INGREDIENTS
Aloe Vera, Arnica Montana (flower), Carbomer (Ultrez 21), Harpagophytum Progcumbens (root), Edetate Disodium, Origanox WS, PEG 33, PEG 8 Dimethicone, PEG-14, Mentha Piperita (leaf), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Potassium Sorbate, Water, Sodium Hydroxide, Ascorbic Acid, Vitamin E Oil, Salix Alba (bark), Hamamelis Virginiana (bark)
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS AND USAGE
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARNICA PLUS
arnica montana, hamamelis virginiana, rhus toxicodendron gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 6 [hp_X] in 1 g HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY) (HAMAMELIS VIRGINIANA BARK - UNII:IH3063S9MY) HAMAMELIS VIRGINIANA BARK 6 [hp_X] in 1 g TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89) EDETATE DISODIUM (UNII: 7FLD91C86K) OREGANO (UNII: 0E5AT8T16U) POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A) PEG-8 DIMETHICONE (UNII: GIA7T764OD) POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R) MENTHA PIPERITA LEAF (UNII: A389O33LX6) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) ASCORBIC ACID (UNII: PQ6CK8PD0R) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) SALIX ALBA BARK (UNII: 205MXS71H7) HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0021-1 105 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 03/14/2013 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0021)