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NDC 69676-0044-02 Genexa Arnica Pain 30; 6; 6; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Genexa Arnica Pain 30; 6; 6; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Genexa Arnica Pain is a ORAL TABLET, CHEWABLE in the HUMAN OTC DRUG category. It is labeled and distributed by Genexa Inc.. The primary component is ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF.

Product Information

NDC	69676-0044
Product ID	69676-0044_e4910702-42fd-6cec-e053-2995a90a5692
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	Genexa Arnica Pain
Proprietary Name Suffix	n/a
Non-Proprietary Name	Arnica montana, Calendula officinalis, Ledum palustre, Rhus toxicodendron, Ruta graveolens
Product Type	HUMAN OTC DRUG
Dosage Form	TABLET, CHEWABLE
Route	ORAL
Active Ingredient Strength	30; 6; 6; 6; 12
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; LEDUM PALUSTRE TWIG; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF
Labeler Name	Genexa Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69676-0044-02 (69676004402)

Pricing Information	N/A
NDC Package Code	69676-0044-2
Billing NDC	69676004402
Package	1 BOTTLE, PLASTIC in 1 CARTON (69676-0044-2) / 100 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC
Marketing Start Date	2020-12-20
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL b6fcbd3a-f5ba-e70d-e053-2995a90a8769 Details

SPL UNCLASSIFIED SECTION

Keep outer package for complete product information

Drug Facts

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Active ingredients‡**

Arnica montana 30X HPUS

Calendula officinalis 6X HPUS

Ledum palustre 6X HPUS

Rhus toxicodendron 12X HPUS

Ruta graveolens 6X HPUS

‡ Organic

"HPUS" indicates that this ingredient is officially included in the Homeopathic Pharmacopoeia of the United States.

SPL UNCLASSIFIED SECTION

Purpose

trauma, muscle pain, muscle soreness, stiffness, swelling, bruising, strains and sprains

cuts, scrapes and discoloration from bruising

swelling, stiffness and bruising

joint pain, joint soreness and joint stiffness

muscle pain and muscle soreness

SPL UNCLASSIFIED SECTION

Uses*

addresses muscle pain and stiffness due to minor injuries, overexertion and falls.
addresses pain, swelling and discoloration from bruises.

SPL UNCLASSIFIED SECTION

Warnings

Stop use and ask a doctorif symptoms persist for more than 3 days or worsen.

If pregnant or breastfeeding, ask a health professional before use.

Keep out of reach of children.

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Directions

adults and children 12 years of age and older	chew 2 tablets at the onset of symptoms do not swallow whole repeat every 4-6 hours as needed
children 3-11 years of age	chew 1 tablet at the onset of symptoms do not swallow whole repeat every 4-6 hours as needed
children under 3 years of age	ask a doctor before use

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Other information

store between 20-25° C (68-77° F) in a dry place out of direct sunlight

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Inactive ingredients

organic carnauba wax, organic dextrose, grape flavor, organic maltodextrin, organic rice bran extract

SPL UNCLASSIFIED SECTION

Questions?

1-855-436-3921

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* CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE; NOT ACCEPTED MEDICAL EVIDENCE. NOT EVALUATED BY THE FOOD AND DRUG ADMINISTRATION

** X is a homeopathic dilution: see genexa.com for more information

SPL UNCLASSIFIED SECTION

Bottle is safety sealed with a perforated band around bottle. DO NOT use if bottle seal is disturbed or missing.

Patent Pending | Distributed by:

Genexa Inc. Atlanta, GA 30318

genexa.com

Certified Organic by SCS Global Services

SPL UNCLASSIFIED SECTION

Made in the USA with globally sourced ingredients

R-20220209

NDC 69676-0044-2

PRINCIPAL DISPLAY PANEL

Genexa®

Arnica Pain

Organic Pain Relief Formula*

Muscle Pain & Soreness*

Bruises & Swelling*

Joint Pain & Stiffness*

Made without: common allergens, artificial dyes, or parabens

Homeopathic

100 Chewable Tablets

Grape Flavor

INGREDIENTS AND APPEARANCE

GENEXA ARNICA PAIN

arnica montana, calendula officinalis, ledum palustre, rhus toxicodendron, ruta graveolens tablet, chewable

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69676-0044
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A)	TOXICODENDRON PUBESCENS LEAF	12 [hp_X]
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	30 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	6 [hp_X]
LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P)	LEDUM PALUSTRE TWIG	6 [hp_X]
RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S)	RUTA GRAVEOLENS FLOWERING TOP	6 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
CARNAUBA WAX (UNII: R12CBM0EIZ)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
RICE BRAN (UNII: R60QEP13IC)
DEXTROSE (UNII: IY9XDZ35W2)

Product Characteristics
Color	white (Off-white)	Score	no score
Shape	ROUND	Size	10mm
Flavor	GRAPE	Imprint Code	G
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69676-0044-2	1 in 1 CARTON	12/20/2020
1		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		12/20/2020

Labeler - Genexa Inc. (079751024)

Revised: 7/2022

Document Id: e4910702-42fd-6cec-e053-2995a90a5692

Set id: b6fcbd3a-f5ba-e70d-e053-2995a90a8769

Version: 3

Effective Time: 20220724

Search by Drug Name or NDC

NDC 69676-0044-02 Genexa Arnica Pain 30; 6; 6; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Genexa Arnica Pain 30; 6; 6; 6; 12 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Product Information

Package

Package Images

NDC 69676-0044-02 (69676004402)

Contents

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PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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