ARNICA GEL 90- arnica montana flower water gel 
OFFICINALIS SRL SOCIETA' AGRICOLA

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ARNICA gel 90% (86049-001)

Active Ingredient


Arnica Montana Flower Water

Ingredients

Arnica Montana Flower Extract, Sodium Hydroxide, Glycerin, Propylene Glycol, Carbomer, Hydogenated Castor Oil, Mentha Piperita Oil, Salvia Officinalis Extract, Thymus Vulgaris Extract, Phenoxyethanol, Benzyl Alcohol, Potassium Sorbate, Tocopherol, EDTA.

Directions:

clean the area thoroughly, massage the product where needed until it is completely absorbed. Do not apply product on open wounds.

External Use Only

The nature of Horses
OFFICINALIS®

with Arnica Montana and Thyme Oil

www.officinalis.net

500ml e 17fl.oz.

Produced by /

Azienda Agricola OFFICINALIS
Via Pedervia, 1
36040 Grancona (VI) ITALIA

www.officinalis.net

Distributed by /

BRUNO DALLA GRANA MANGIMI srl
Via Zara, 74
36045 Lonigo (VI) - ITALIA
Tel. (0039) 0444 830501
dallagranamangimi@libero.it

LABEL1

ARNICA GEL 90 
arnica montana flower water gel
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86049-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA FLOWER WATER (UNII: U7L2JP51PR) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ) ARNICA MONTANA FLOWER820 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
THYME (UNII: CW657OBU4N)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
TOCOPHEROL (UNII: R0ZB2556P8)  
EDETIC ACID (UNII: 9G34HU7RV0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86049-001-01500 mL in 1 BOTTLE
2NDC:86049-001-021000 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/18/2015
Labeler - OFFICINALIS SRL SOCIETA' AGRICOLA (441513267)
Establishment
NameAddressID/FEIBusiness Operations
OFFICINALIS SRL SOCIETA' AGRICOLA441513267manufacture, api manufacture

Revised: 12/2023
Document Id: ebb0b80b-582e-4178-b182-abde4cfd8087
Set id: a23a57e3-603b-4d71-8e5c-57a5c3444a69
Version: 9
Effective Time: 20231219
 
OFFICINALIS SRL SOCIETA' AGRICOLA