ARNICA- arnica montana liquid 
BioActive Nutritional, 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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Drug Facts:

ACTIVE INGREDIENTS:

Arnica Montana 3X.

INDICATIONS:

For temporary relief of conditions caused by injuries, contusions, blows and falls.

WARNINGS:

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in cool, dry place.

DIRECTIONS:

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

Demineralized Water, 25% Ethanol.

KEEP OUT OF REACH OF CHILDREN:

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS:

For temporary relief of conditions caused by injuries, contusions, blows and falls.

QUESTIONS:

Distributed by:
BioActive Nutritional, Inc.
1803 N. Wickham Rd.
Melbourne, FL 32935
bioactivenutritional.com

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

ARNICA 3X

HOMEOPATHIC

1 FL OZ (30 ml)

Arnica 3X

ARNICA 
arnica montana liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43857-0070
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA ROOT (UNII: MUE8Y11327) (ARNICA MONTANA ROOT - UNII:MUE8Y11327) ARNICA MONTANA ROOT 3 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43857-0070-1 30 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product 02/23/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 10/08/2012
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
Name Address ID/FEI Business Operations
Apotheca Company 844330915 manufacture(43857-0070) , api manufacture(43857-0070) , label(43857-0070) , pack(43857-0070)

Revised: 2/2017
Document Id: 08227eaf-52f4-423c-8fa5-91f2a2e4b489
Set id: 47a19950-47c3-4559-88c4-7728f71964b9
Version: 3
Effective Time: 20170223
 
BioActive Nutritional, Inc.