Label: ARNICA- arnica montana pellet
- NDC Code(s): 0220-0508-41, 0220-0508-43
- Packager: Laboratoires Boiron
- 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 January 5, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
-
STOP USE
Stop use and ask a doctor if symptoms persist for more than 3 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.
Stop use and ask a doctor if symptoms persist for more than 7 days or worsen, new symptoms occur, or if redness or swelling is present. These could be signs of a serious condition.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
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SPL UNCLASSIFIED SECTION
- do not use if glued carton end flaps are open or if the pellet dispenser seal is broken.
- contains 0.25 g of sugar per dose
Pain Relief"
Muscle Pain & Stiffness, Swelling from Injuries, Bruises*
Bruise Relief*
Discoloration Pain Swelling*
No Known Drug Interactions
Plant-Powered Relief
No Artificial Colors, Flavors, Sweeteners, or Preservatives
How to dispense pellets? Turn tube upside down Twist until 5 pellets are dispensed Remove the cap and pour pellets under the tongue.
16 Doses per Tube
3 Tubes approx. 80 quick dissolving pellets per tube
Total 240 Pellets
*Claims are based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated
**C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ARNICA
arnica montana pelletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-0508 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA 30 [hp_C] Inactive Ingredients Ingredient Name Strength SUCROSE (UNII: C151H8M554) LACTOSE (UNII: J2B2A4N98G) Product Characteristics Color white Score no score Shape ROUND (Pellet) Size 4mm Flavor Imprint Code ; Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-0508-43 3 in 1 PACKAGE 05/01/2009 1 NDC:0220-0508-41 80 in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0220-0508-41 80 in 1 TUBE; Type 0: Not a Combination Product 05/01/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 05/01/2009 Labeler - Laboratoires Boiron (282560473) Registrant - Boiron Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-0508)
