ARNICA PAIN RELIEF- rhus spp. whole, arnica montana, calendula officinalis whole, ledum palustre whole and ruta graveolens whole tablet, chewable 
Genexa LLC

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 Label and Listing

Warning Section

Warnings

Ask a doctor before use in children under
5 years of age. Stop use and ask a doctor if
symptoms persist for more than 3 days or worsen.
If pregnant or breastfeeding, ask a doctor before
use. Keep out of reach of children.

  • temporarily relieves muscle pain and stiffness

due to minor injuries, overexertion and falls

  • reduces pain, swelling and discoloration

from bruises

Package Label.Principal Display Panel

Arnica

Warning and Precautions Section

WarningsAsk a doctor before use in children under
5 years of age. Stop use and ask a doctor if
symptoms persist for more than 3 days or worsen.
If pregnant or breastfeeding, ask a doctor before
use. Keep out of reach of children.

Dosage & Administration Section

for best results, use at the first sign of
symptoms and continue to use until symptoms
completely subside.

  • adults and children over 12 years of ageand older:
  • chew 2 tablets at the onset of symptoms.
  • Do not swallow whole. Repeat every 4-6 hoursuntil symptoms are gone.
  • children 5-11 years of age:
  • chew 1 tablet at the onset of symptoms. Do not swallow whole. Repeat every 4-6 hours untilsymptoms are gone.
  • children under 5 years of age: ask a doctor before use.

Inactive Ingredient Section

Organic Tapioca Dextrose, Organic Maltodextrin,
Organic Carnauba Wax, Organic Rice Bran Extract,
Microcrystalline Cellulose, Organic Compliant
Natural Flavor

OTC - Purpose Section

  • temporarily relieves muscle pain and stiffness

due to minor injuries, overexertion and falls

  • reduces pain, swelling and discoloration

from bruises

OTC - Active Ingredient Section

Arnica montana 30X HPUS.......trauma, muscle pain,
muscle soreness, stiffness,
swelling and bruising
Calendula officinalis 6X HPUS.......cuts, scrapes and
discoloration from bruising
Ledum palustre 6X HPUS..............swelling, stiffness
and bruising
Rhus toxicodendron 12X HPUS.................joint pain,
joint soreness and
joint stiffness
Ruta graveolens 6X HPUS...............muscle pain and
muscle soreness
“HPUS” indicates that this ingredient is officially
included in the Homeopathic

OTC - Keep Out of Reach of Children Section

Ask a doctor before use in children under
5 years of age. Stop use and ask a doctor if
symptoms persist for more than 3 days or worsen.
If pregnant or breastfeeding, ask a doctor before
use. Keep out of reach of children.

ARNICA PAIN RELIEF 
arnica montana, calendula officinalis, ledum palustre, rhus toxicodendron, ruta graveolens tablet, chewable
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69676-0013
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
RHUS SPP. WHOLE (UNII: 3U7FG9T9MW) (RHUS SPP. WHOLE - UNII:3U7FG9T9MW) RHUS SPP. WHOLE12 [hp_X]  in 1 [hp_X]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA30 [hp_X]  in 1 [hp_X]
CALENDULA OFFICINALIS WHOLE (UNII: PFR03EBU0H) (CALENDULA OFFICINALIS WHOLE - UNII:PFR03EBU0H) CALENDULA OFFICINALIS WHOLE6 [hp_X]  in 1 [hp_X]
LEDUM PALUSTRE WHOLE (UNII: 1N8KG72C5M) (LEDUM PALUSTRE WHOLE - UNII:1N8KG72C5M) LEDUM PALUSTRE WHOLE6 [hp_X]  in 1 [hp_X]
RUTA GRAVEOLENS WHOLE (UNII: 181JI0338P) (RUTA GRAVEOLENS WHOLE - UNII:181JI0338P) RUTA GRAVEOLENS WHOLE6 [hp_X]  in 1 [hp_X]
Inactive Ingredients
Ingredient NameStrength
DEXTROSE (UNII: IY9XDZ35W2)  
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize10mm
FlavorBERRYImprint Code D;60
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69676-0013-240 [hp_X] in 1 BLISTER PACK; Type 0: Not a Combination Product08/24/201502/23/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/24/201502/23/2016
Labeler - Genexa LLC (079751024)
Registrant - Genexa LLC (079751024)
Establishment
NameAddressID/FEIBusiness Operations
Genexa LLC079751024relabel(69676-0013)

Revised: 3/2016
 
Genexa LLC