Label: ARNICARE- arnica montana gel
0220-9000-66, view more0220-9000-84, 0220-9000-86
- 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.
Updated October 21, 2021
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- ACTIVE INGREDIENT
- INDICATIONS & USAGE
For external use only.
Do not use if you are allergic to Arnica montana or to any of this product's inactive ingredients.
When using this product
avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
use only as directed
dryness or irritation may occur
do not tightly wrap or bandage the treated area
do not apply heat or ice to treated area immediately before or after use.
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
Apply a thin layer of Arnicare Gel to the 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
Arnicare Gel Roll-On - Shake well before each use. With the applicator facing down, lightly squeeze the tube then roll ball against skin to apply a thin layer of the product to affected area. Massage gently into skin 3 times a day or as needed. If heat or ice is applied, wait 5 minutes before applying Arnicare Roll-on.
- INACTIVE INGREDIENT
SPL UNCLASSIFIED SECTION
do not use if glued carton end flaps are open or if the tube seal is broken
0.5 oz (14g)
1.5 oz (45g)
2.6 oz (75g)
4.2 oz (120g)
Muscle Pain & Stiffness Swelling from Injuries Bruises*
Homeopathic mother tincture made from Arnica montana fresh whole plant.
*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
arnica montana gel
Product Information Product Type HUMAN OTC DRUG 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) 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 NDC:0220-9000-66 1 in 1 PACKAGE 01/09/2007 1 120 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0220-9000-59 1 in 1 PACKAGE 01/09/2007 2 75 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:0220-9000-54 1 in 1 PACKAGE 01/09/2007 3 45 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:0220-9000-65 1 in 1 PACKAGE 01/09/2007 4 14 g in 1 TUBE; Type 0: Not a Combination Product 5 NDC:0220-9000-84 1 in 1 PACKAGE 06/01/2018 5 45 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:0220-9000-86 2 in 1 PACKAGE 06/01/2018 6 45 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 01/09/2007 Labeler - Laboratoires Boiron (282560473) Registrant - Boiron Inc. (014892269) Establishment Name Address ID/FEI Business Operations Boiron 282560473 manufacture(0220-9000)