FDA.reportPublic FDA data

Arnica Recovery

Manufacturer
NARTEX LABORATORIOS HOMEOPATICOS SA DE CV
Effective date
2018-02-27
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 02:09:16

Label at a glance#

ProductArnica Recovery
Active ingredientARNICA MONTANA
Label structure14 sections

Storage and handling

store in a cool and dry place

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Arnica montana 6C HPUS

OTC - PURPOSE SECTION

Arnica montana.......6C HPUS*..........Anti-inflammatory

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.  C is a homeopathic dilution.  See www.nartexlabsusa.com for more information.  Active ingredients are preparaed in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

INDICATIONS & USAGE SECTION

 For the temporary relief of

  • sore muscles
  • bruises
  • sprains

as per homeopathic materia medica

Product uses are based on Homeopathic Materia Medica.  These "Uses" have not been evaluated by teh Food and Drug Administration. This product has not been clinically tested by Nartex Labs USA, Inc.

WARNINGS SECTION

Do not use if you have an allergy or hypersensitivity to the components of the formula.

OTC - STOP USE SECTION

Stop and ask a physician if:

  • condition worsens
  • if symptoms persist for more than 7 days or clear up and occur again within a few days
  • rash develops

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • adults and children 4 years of age and older: take 2 tablets every 6 hours, slowly dissolving in mouth
  • children under 4 years of age: consult a physician

STORAGE AND HANDLING SECTION

store in a cool and dry place

INACTIVE INGREDIENT SECTION

Gelatin, lactose, magnesium stearate, potato starch, talc

OTC - QUESTIONS SECTION

Questions or comments?  informacion@nartexlabs.com or call 1-877-248-1970 between 9am and 5pm CST

DESCRIPTION SECTION

Distributed by:

Nartex Labs USA, Inc.

11711 Memorial Dr. #685

Houston TX 77024

www.nartexlabsusa.com

DESCRIPTION SECTION

Product claims are based on Homeopathic Materia Medica. This product has not been clinically tested by Nartex.

Keep carton. It contains important information.

For you protection, this bottle has a seal around the neck.  Attention: do not use if hte neck seal is broken.

This product is HOMEOPATHIC.  Its claim and efficacy are based on homeopathic research and clinical experience.  This product has not been evaluated for efficacy by FDA with the same rules and procedures as those for other non-homeopathic drugs.  For more information on homeopathy visit www.nartexlabsusa.com before using this product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 34666-010-60

Arnica

Recovery Nartex

For Sore Muscles and Bruises*

Directions

2 tablets every 6 hours**

Homeopathic

60 Tablets

*Based on Homeopathic Materia Medica

**See directions at the Back.

ArnicaTabletsCartonArnicaTabletsCarton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34666-010-12Arnica Recovery12 in 1 BLISTER PACKTABLET1210
34666-010-60Arnica Recovery60 in 1 BLISTER PACKTABLET6010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34666-010ARNICA RECOVERY (ARNICA MONTANA) TABLET [NARTEX LABORATORIOS HOMEOPATICOS SA DE CV]10Current NDC, Legacy NDC, 2 package rows20180228_e9e22991-48a0-4e66-bd6f-267f3e8badd6.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW2
ARNICA MONTANAACTIVE MOIETYO80TY208ZW2
GELATININACTIVE INGREDIENT2G86QN327L2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98G2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3T2
TALCINACTIVE INGREDIENT7SEV7J4R1U2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
34666-01034666-010-60, 34666-010-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
GELATIN2G86QN327LIACT
LACTOSEJ2B2A4N98GIACT
MAGNESIUM STEARATE70097M6I30IACT
STARCH, POTATO8I089SAH3TIACT
TALC7SEV7J4R1UIACT
ARNICA MONTANAO80TY208ZWACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / ORAL46 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / ORAL46 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, POTATOSTARCH, POTATO8I089SAH3TTABLET / ORAL458 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
LACTOSELACTOSEJ2B2A4N98GTABLET / ORAL2500 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, POTATOSTARCH, POTATO8I089SAH3TTABLET / ORAL458 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET / ORAL46 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
STARCH, POTATOSTARCH, POTATO8I089SAH3TTABLET / ORAL458 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Arnica RecoveryARNICA MONTANANARTEX LABORATORIOS HOMEOPATICOS SA DE CVe9e22991-48a0-4e66-bd6f-267f3e8badd62018-02-27WarningsExact identifier
ndc (package): 34666-010-60
ndc (package): 34666-010-12
ndc (product): 34666-010
ndc11 (package): 34666001060
ndc11 (package): 34666001012
spl id: 6637cdc3-5654-4469-e053-2991aa0abb48
spl set id: e9e22991-48a0-4e66-bd6f-267f3e8badd6

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.