Label: ARNICA ACTIVE ROLL-ON- arnica montana liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 59262-102-42 - Packager: Similasan Corporation
- 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 December 12, 2016
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- SPL UNCLASSIFIED SECTION
- Active Ingredients
- Purpose
- Uses*
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Warnings
• FOR EXTERNAL USE ONLY. Do not use on damaged skin, open wounds, or mucous membranes.
• According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).
• Avoid contact with the eyes.
• Do not use if you are allergic to Arnica montana (Asteracea flower) or any of this product’s inactive ingredients.
• Do not bandage tightly or use with a heating pad.
• If conditions worsen or if symptoms persist for more than 72 hours or clear up and occur again within a few days, discontinue use of this product and consult a physician.
- Directions
- Other Information
- Inactive Ingredients
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARNICA ACTIVE ROLL-ON
arnica montana liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59262-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 1 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) SODIUM HYDROXIDE (UNII: 55X04QC32I) ALCOHOL (UNII: 3K9958V90M) PEG-8 DIMETHICONE (UNII: GIA7T764OD) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59262-102-42 74 mL in 1 APPLICATOR; Type 0: Not a Combination Product 02/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 02/01/2017 Labeler - Similasan Corporation (111566530)