Arnica Montana: Homeopathic Product Information

ARNICA MONTANA- arnica montana pellet
Hahnemann Laboratories, 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.

Arnica Montana 6C 5g
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Arnica Montana 6C 30g
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Arnica Montana 6C 100g
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Arnica Montana 12C 5g
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Arnica Montana 12C 30g
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Arnica Montana 12C 100g
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Arnica Montana 30C 1g
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Arnica Montana 30C 5g
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Arnica Montana 30C 30g
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Arnica Montana 30C 100g
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Arnica Montana 100C 1g
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Arnica Montana 100C 5g
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Arnica Montana 100C 30g
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Arnica Montana 100C 100g
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Arnica Montana 200C 1g
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Arnica Montana 200C 5g
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Arnica Montana 200C 30g
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Arnica Montana 200C 100g
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Arnica Montana 500C 1g
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Arnica Montana 500C 5g
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Arnica Montana 500C 30g
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Arnica Montana 500C 100g
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Arnica Montana 1M 1g
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Arnica Montana 1M 5g
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Arnica Montana 1M 30g
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Arnica Montana 1M 100g
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Arnica Montana 10M 1g
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Arnica Montana 10M 5g
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Arnica Montana 10M 30g
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Arnica Montana 10M 100g
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Arnica Montana LM1 30g
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ARNICA MONTANA
arnica montana pellet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-166
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 10 [hp_M]
Inactive Ingredients
Ingredient Name Strength
SUCROSE
Product Characteristics
Color white Score no score
Shape ROUND Size 2mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63545-166-01 200 PELLET in 1 VIAL, GLASS None
2 NDC:63545-166-02 500 PELLET in 1 VIAL, GLASS None
3 NDC:63545-166-03 3000 PELLET in 1 BOTTLE, GLASS None
4 NDC:63545-166-04 10000 PELLET in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 03/12/2021
ARNICA MONTANA
arnica montana pellet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-165
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 1 [hp_M]
Inactive Ingredients
Ingredient Name Strength
SUCROSE
Product Characteristics
Color white Score no score
Shape ROUND Size 2mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63545-165-01 200 PELLET in 1 VIAL, GLASS None
2 NDC:63545-165-02 500 PELLET in 1 VIAL, GLASS None
3 NDC:63545-165-03 3000 PELLET in 1 BOTTLE, GLASS None
4 NDC:63545-165-04 10000 PELLET in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 03/12/2021
ARNICA MONTANA
arnica montana pellet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-162
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 100 [hp_C]
Inactive Ingredients
Ingredient Name Strength
SUCROSE
Product Characteristics
Color white Score no score
Shape ROUND Size 2mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63545-162-01 200 PELLET in 1 VIAL, GLASS None
2 NDC:63545-162-02 500 PELLET in 1 VIAL, GLASS None
3 NDC:63545-162-03 3000 PELLET in 1 BOTTLE, GLASS None
4 NDC:63545-162-04 10000 PELLET in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 03/12/2021
ARNICA MONTANA
arnica montana pellet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-167
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 1 [hp_Q]
Inactive Ingredients
Ingredient Name Strength
SUCROSE
Product Characteristics
Color white Score no score
Shape ROUND Size 1mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63545-167-01 10000 PELLET in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 03/12/2021
ARNICA MONTANA
arnica montana pellet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-159
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 6 [hp_C]
Inactive Ingredients
Ingredient Name Strength
SUCROSE
Product Characteristics
Color white Score no score
Shape ROUND Size 3mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63545-159-01 200 PELLET in 1 VIAL, GLASS None
2 NDC:63545-159-02 1200 PELLET in 1 BOTTLE, GLASS None
3 NDC:63545-159-03 4000 PELLET in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 03/12/2021
ARNICA MONTANA
arnica montana pellet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-164
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 500 [hp_C]
Inactive Ingredients
Ingredient Name Strength
SUCROSE
Product Characteristics
Color white Score no score
Shape ROUND Size 2mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63545-164-01 200 PELLET in 1 VIAL, GLASS None
2 NDC:63545-164-02 500 PELLET in 1 VIAL, GLASS None
3 NDC:63545-164-03 3000 PELLET in 1 BOTTLE, GLASS None
4 NDC:63545-164-04 10000 PELLET in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 03/12/2021
ARNICA MONTANA
arnica montana pellet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-160
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 12 [hp_C]
Inactive Ingredients
Ingredient Name Strength
SUCROSE
Product Characteristics
Color white Score no score
Shape ROUND Size 3mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63545-160-01 200 PELLET in 1 VIAL, GLASS None
2 NDC:63545-160-02 1200 PELLET in 1 BOTTLE, GLASS None
3 NDC:63545-160-03 4000 PELLET in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 03/12/2021
ARNICA MONTANA
arnica montana pellet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-161
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 30 [hp_C]
Inactive Ingredients
Ingredient Name Strength
SUCROSE
Product Characteristics
Color white Score no score
Shape ROUND Size 3mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63545-161-01 80 PELLET in 1 VIAL, GLASS None
2 NDC:63545-161-02 200 PELLET in 1 VIAL, GLASS None
3 NDC:63545-161-03 1200 PELLET in 1 BOTTLE, GLASS None
4 NDC:63545-161-04 4000 PELLET in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 03/12/2021
ARNICA MONTANA
arnica montana pellet
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63545-163
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ARNICA MONTANA (ARNICA MONTANA) ARNICA MONTANA 200 [hp_C]
Inactive Ingredients
Ingredient Name Strength
SUCROSE
Product Characteristics
Color white Score no score
Shape ROUND Size 2mm
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63545-163-01 200 PELLET in 1 VIAL, GLASS None
2 NDC:63545-163-02 500 PELLET in 1 VIAL, GLASS None
3 NDC:63545-163-03 3000 PELLET in 1 BOTTLE, GLASS None
4 NDC:63545-163-04 10000 PELLET in 1 BOTTLE, GLASS None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 03/12/2021
Labeler — Hahnemann Laboratories, Inc. (147098081)
Registrant — Hahnemann Laboratories, Inc. (147098081)
Establishment
Name Address ID/FEI Operations
Hahnemann Laboratories, Inc. 147098081 manufacture (63545-159), manufacture (63545-160), manufacture (63545-161), manufacture (63545-162), manufacture (63545-163), manufacture (63545-164), manufacture (63545-165), manufacture (63545-166), manufacture (63545-167)

Revised: 03/2021 Hahnemann Laboratories, Inc.

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