Label: ARNICA PLUS- arnica montana, hamamelis virginiana, rhus tox, whey protein gel
- NDC Code(s): 43846-0065-1
- 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 July 20, 2016
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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:
Purified Water, Vitis Vinifera (Grape Seed Oil), Whey Protein, Lecithin (Soy), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Arnica Montana (Flower), Aloe Barbadensis Leaf, Salix Alba Bark (White Willow), Polysorbate 20, Hamamelis Virginiana Bark (Witch Hazel), Sodium Hydroxide, Ascorbic Acid, Harpagophytum Procumbens Root (Devil’s Claw), Tocopherols (Soy), Mentha Piperita Leaf (Peppermint), Edetate Disodium, Oregano, Potassium Sorbate
- QUESTIONS:
- PACKAGE LABEL DISPLAY:
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INGREDIENTS AND APPEARANCE
ARNICA PLUS
arnica montana, hamamelis virginiana, rhus tox, whey protein gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43846-0065 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 WHEY (UNII: 8617Z5FMF6) (WHEY - UNII:8617Z5FMF6) WHEY 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) VITIS VINIFERA SEED (UNII: C34U15ICXA) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) PHENOXYETHANOL (UNII: HIE492ZZ3T) CAPRYLYL GLYCOL (UNII: 00YIU5438U) SORBIC ACID (UNII: X045WJ989B) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) ALOE VERA LEAF (UNII: ZY81Z83H0X) SALIX ALBA BARK (UNII: 205MXS71H7) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM HYDROXIDE (UNII: 55X04QC32I) ASCORBIC ACID (UNII: PQ6CK8PD0R) HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89) TOCOPHEROL (UNII: R0ZB2556P8) MENTHA PIPERITA LEAF (UNII: A389O33LX6) EDETATE DISODIUM (UNII: 7FLD91C86K) OREGANO (UNII: 0E5AT8T16U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0065-1 1814 g in 1 JUG; Type 0: Not a Combination Product 07/20/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/20/2016 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0065) , api manufacture(43846-0065) , label(43846-0065) , pack(43846-0065)
