Label: ARNICA PLUS- arnica montana, hamamelis virginiana bark and toxicodendron pubescens leaf gel
- NDC Code(s): 43846-0026-1
- Packager: Peaceful Mountain, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- ACTIVE INGREDIENTS
Arnica Montana 6X,12X, Hamamelis Virginiana 6X,12X, Rhus Toxicodendron 6X,12X.Close
For temporary relief of minor symptoms of sore, overexerted muscles.
These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug
For external use only. If pregnant or breastfeeding, 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.Close
Apply at least 3 times daily over the affected area.Close
- INACTIVE INGREDIENTS
Aloe Vera 10X Concentrate, Arnica (Flower) Arnica Montana, Carbomer (ULTREZ 21), Harpagophytum Procumbens (root), Edetate Disodium (EDTA), Origanox WS, PEG-33, PEG-8 Dimethicone, PEG-14 (Silsense, Copolyol 1 Silicone), Mentha Piperita (leaf), Phenoxyethanol and Caprylyl Glycol, Sorbic Acid (Optiphen Plus), Potassium Sorbate, Purified Water, Sodium Hydroxide (Solution), Ascorbic Acid, Vitamin E Oil (derived from Soy Bean), Salix Alba (bark), Hamamelis Virginiana.Close
- 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.Close
- INDICATIONSAND USAGE
For the temporary relief of minor symptoms of sore, overexerted muscles.Close
Dist. by Peaceful Mountain, Inc.
Woodbine, IA 51579
- PRINCIPAL DISPLAY PANEL
THE HEIGHT OF HEALTH
wild crafted herbs
formulated in boulder, co
Net wt. 4 lbs. (64 oz.) (1.8 kg)
- INGREDIENTS AND APPEARANCE
arnica montana, hamamelis virginiana, rhus toxicodendron gel
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:43846-0026 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 6 [hp_X] in 1 g HAMAMELIS VIRGINIANA BARK (HAMAMELIS VIRGINIANA BARK) HAMAMELIS VIRGINIANA BARK 6 [hp_X] in 1 g TOXICODENDRON PUBESCENS LEAF (TOXICODENDRON PUBESCENS LEAF) TOXICODENDRON PUBESCENS LEAF 6 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF ARNICA MONTANA FLOWER CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) HARPAGOPHYTUM PROCUMBENS ROOT EDETATE DISODIUM ORIGANUM VULGARE SUBSP. HIRTUM FLOWER PEG-8 DIMETHICONE POLYETHYLENE GLYCOL 1500 POLYETHYLENE GLYCOL 700 MENTHA PIPERITA LEAF PHENOXYETHANOL CAPRYLYL GLYCOL SORBIC ACID POTASSIUM SORBATE WATER SODIUM HYDROXIDE ASCORBIC ACID ALPHA-TOCOPHEROL SALIX ALBA BARK Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:43846-0026-1 1814 g in 1 JUG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 10/11/2012 Labeler - Peaceful Mountain, Inc. (078430707) Registrant - Apotheca Company (844330915) Establishment Name Address ID/FEI Business Operations Apotheca Company 844330915 manufacture(43846-0026)