Search by Drug Name or NDC

NDC 65111-0005-77 Arnica Montana 30 [hp_X]/1 Details

Arnica Montana 30 [hp_X]/1

Arnica Montana is a ORAL TABLET in the HUMAN OTC DRUG category. It is labeled and distributed by Vitamedica Corporation. The primary component is ARNICA MONTANA.

Product Information

NDC	65111-0005
Product ID	65111-005_b3fc45c7-c208-4194-82a2-ad311dce494e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Arnica Montana
Proprietary Name Suffix	n/a
Non-Proprietary Name	Arnica Montana
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET
Route	ORAL
Active Ingredient Strength	30
Active Ingredient Units	[hp_X]/1
Substance Name	ARNICA MONTANA
Labeler Name	Vitamedica Corporation
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	n/a

Package

Package Images

NDC 65111-0005-77 (65111000577)

Pricing Information	N/A
NDC Package Code	65111-005-77
Billing NDC	65111000577
Package	1 BLISTER PACK in 1 CARTON (65111-005-77) / 30 TABLET in 1 BLISTER PACK
Marketing Start Date	2014-11-17
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL a134a2a4-2faa-4ef2-8af1-7f8be420f32b Details

ACTIVE INGREDIENT:

Arnica Montana 30X.

PURPOSE:

Anti-Inflammatory

WARNINGS:

If pregnant or breast-feeding ask a health professional before use. Discontinue use if any adverse reactions occur. Contact your physician, if symptoms do not subside within 14 days.

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 seal is broken or shows any signs of tampering.

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.

DIRECTIONS:

Adults, three tablets, three times a day. Not intended for children under 12 years of age. This product is a sublingual application.

INDICATION:

Anti-Inflammatory

INACTIVE INGREDIENTS:

Copovidone, Crospovidone, Lactose, Magnesium Stearate, Mannitol, Microcrystalline Cellulose, Silicon Dioxide, and Sorbitol.

QUESTIONS:

Formulated and Distributed

by VitaMedica Corp.

Torrance, CA 90502

888-367-8605 VitaMedica.com

NDC 65111-005-67

PACKAGE DISPLAY LABEL

VitaMedica

Arnica Montana

30X HPUS

REDUCES

Bruising, Swelling & Pain

NATURAL REMEDY

STIMULATES HEALING

Recommended by Plastic Surgeons

Homeopathic Medicine

150 Sublingual Tablets

INGREDIENTS AND APPEARANCE

ARNICA MONTANA

arnica montana tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65111-005
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
COPOVIDONE K25-31 (UNII: D9C330MD8B)
CROSPOVIDONE (UNII: 2S7830E561)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MANNITOL (UNII: 3OWL53L36A)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	white	Score	no score
Shape	ROUND (TABLET)	Size	6mm
Flavor		Imprint Code	V
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:65111-005-67	150 in 1 BOTTLE; Type 0: Not a Combination Product	08/12/2021	09/22/2026

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/12/2021	09/22/2026

Labeler - Vitamedica Corporation (808198779)

Registrant - Apotheca Company (844330915)

Name	Address	ID/FEI	Business Operations
Establishment
Apotheca Company		844330915	manufacture(65111-005) , api manufacture(65111-005) , label(65111-005) , pack(65111-005)

Revised: 3/2022

Document Id: b3fc45c7-c208-4194-82a2-ad311dce494e

Set id: a134a2a4-2faa-4ef2-8af1-7f8be420f32b

Version: 2

Effective Time: 20220314