Label: ARNICARE VALUE PACK- arnica montana kit
- NDC Code(s): 0220-9042-79
- 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 November 27, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- PURPOSE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
ARNICARE GEL: Apply a thin layer of Arnicare Gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare Gel.
ARNICA 30C PELLETS: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
- INACTIVE INGREDIENT
- QUESTIONS
-
SPL UNCLASSIFIED SECTION
do not use if glued carton end flaps are open, if the tube seal is broken, or if pellet dispenser seal is broken
Quickly absorbed, non-greasy, fragrance-free, non-drowsy, no known drug interactions
Pain Relief*
Muscle Pain & Stiffness Swelling from Injuries Bruises*
Local & General Pain
Combine for Total Relief
Gel: 1 tube 2.6 oz (75g)
Pellets: + approx. 80 pellets
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*CLAIMS 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.
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ARNICARE VALUE PACK
arnica montana kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0220-9042 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0220-9042-79 1 in 1 KIT 11/01/2008 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 80 Part 2 1 TUBE 75 g Part 1 of 2 ARNICA
arnica montana pelletProduct Information 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 80 in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/01/2008 Part 2 of 2 ARNICARE
arnica montana gelProduct Information Item Code (Source) NDC:0220-9000 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 g Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) DIMETHICONE (UNII: 92RU3N3Y1O) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 75 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/01/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/01/2008 Labeler - Laboratoires Boiron (282560473) Registrant - Boiron Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9042)