Label: TRAUMED- arnica root tablet
- NDC Code(s): 62795-2301-2
- Packager: MediNatura 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.
Updated October 11, 2017
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- KEEP OUT OF REACH OF CHILDREN
Directions: At first sign of symptoms:Adults and children 4 years and older:
1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours.
Adults and children 4 years and older:
3 tablets per day, taking 1 tablet every 4 to 6 hours.
Allow tablets to dissolve completely in the mouth, do not swallow
- ACTIVE INGREDIENTS
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
arnica root tablet
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62795-2301 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT 6 [hp_X] Inactive Ingredients Ingredient Name Strength LACTOSE (UNII: J2B2A4N98G) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color white Score no score Shape ROUND Size 9mm Flavor Imprint Code Leafman Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62795-2301-2 100 in 1 BOTTLE; Type 0: Not a Combination Product 10/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 09/30/2014 Labeler - MediNatura Inc. (079324099) Establishment Name Address ID/FEI Business Operations MediNatura Inc. 102783016 manufacture(62795-2301)