Label: ARNICA PLUS- arnica montana, hamamelis virginiana, rhus tox gel
- NDC Code(s): 43846-0075-1
- 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 August 7, 2023
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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 • Conditions worsens • Symptoms last more than 7 days.
Do not use if safety seal is broken or missing.
- KEEP OUT OF REACH OF CHILDREN:
- DIRECTIONS:
- INDICATIONS:
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INACTIVE INGREDIENTS:
Water, Arnica (Arnica Montana) Flower, White Willow (Salix Alba) Bark, Witch Hazel (Hamamelis Virginiana) Bark, Ascorbic Acid, Devil’s Claw (Harpagophytum Procumbens) Root, Peppermint (Mentha Piperita) Leaf, Acrylates/C10-30 Alkyl acrylate Crosspolymer, Alkyl Acrylate Crosspolymer, Aloe Vera Leaf Juice, Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Peg-33, Peg-8 Dimethicone, Peg-14, Sodium Hydroxide, Tocopherols (soy), Disodium EDTA, Natural Plant Extract, Potassium Sorbate, Sodium Benzoate, Ethanol, Citric Acid.
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
ARNICA PLUS
arnica montana, hamamelis virginiana, rhus tox gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0075 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA WHOLE 6 [hp_X] in 1 g HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS) HAMAMELIS VIRGINIANA ROOT BARK/STEM 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 WATER (UNII: 059QF0KO0R) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) SODIUM HYDROXIDE (UNII: 55X04QC32I) POLYETHYLENE GLYCOL 1600 (UNII: 1212Z7S33A) PEG-8 DIMETHICONE (UNII: GIA7T764OD) POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R) ALOE VERA LEAF (UNII: ZY81Z83H0X) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) EDETATE DISODIUM (UNII: 7FLD91C86K) OREGANO (UNII: 0E5AT8T16U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) SALIX ALBA BARK (UNII: 205MXS71H7) HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY) ASCORBIC ACID (UNII: PQ6CK8PD0R) HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89) MENTHA PIPERITA LEAF (UNII: A389O33LX6) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ALCOHOL (UNII: 3K9958V90M) SODIUM BENZOATE (UNII: OJ245FE5EU) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0075-1 57 g in 1 TUBE; Type 0: Not a Combination Product 11/14/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/14/2018 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0075) , api manufacture(43846-0075) , label(43846-0075) , pack(43846-0075)
