ARNICA GEL- arnica montana gel 
King Bio Inc.

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.

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Arnica Gel

Drug Facts__________________________________________________________________________________________________________

Active ingredient:

Arnica montana 1X HPUS*-7%

*HPUS indicates inclusion in the official Homeopathic Pharmacopoeia of the United States.

Uses Temporarily relieves: •swelling form minor injuries •muscle pain and stiffness, •and bruising, due to minor injuries or overexertion. †as per various materia medicas. Product "Uses" have not been evaluated by the FDA. Product has not been clinically tested.

Warnings:

Directions: Apply to affected areas 2 or 3 times daily, or more often as needed. For best results, apply at the onset of symptoms.

Other information:

Inactive ingredients:  Alcohol denat, carbomer, purified water, sodium hydroxide.

Drug Facts

____________________________________________________________________________________________________________________

Active ingredients                                   Purpose†

Arnica montana.......................................Swelling from minor injuries, muscle pain and stiffness, bruising due to minor injuries or overexertion.

*HPUS indicates inclusion in the official Homeopathic Pharmacopoeia of the United States.

image description

ARNICA GEL 
arnica montana gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-3203
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 73 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57955-3203-31 in 1 CARTON
173 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic03/07/2016
Labeler - King Bio Inc. (617901350)
Registrant - King Bio Inc. (617901350)
Establishment
NameAddressID/FEIBusiness Operations
King Bio Inc.617901350manufacture(57955-3203)

Revised: 3/2016
Document Id: 0331c2cb-653c-4f34-a920-17112774a637
Set id: b9c9fddf-3fd2-4420-8d20-f1359078ab8f
Version: 1
Effective Time: 20160317
 
King Bio Inc.