FDA.reportPublic FDA data

Novarnica Sport

Manufacturer
Xcentrik Inc.
Effective date
2022-12-19
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 23:52:33

Label at a glance#

ProductNovarnica Sport
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

For fast and soothing relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Dosage and administration

For adults and children 12 years and older, apply generously and rub on affected area until the cream has penetrated through the skin. Repeat as needed up to 4 times daily. If pain persists or worsens more than seven days, discontinue use and consult a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 3%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For fast and soothing relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

Warnings

WARNINGS SECTION

Allergy Alert: Do not use if allergic to Asteraceae or Compositae (daisy) family or to any other ingredient contained in this product.

  • For external use only.
  • Discontinue use if appearance of rash, irritation, reddening, dermatitis or eczema.
  • Do not apply on wounds.
  • Avoid contact with eyes and mucous membranes.
  • Do not apply bandage or heat (heating pad) on the affected body part.
  • Consult a healthcare practitioner prior to use if you are pregnant or breast-feeding.
  • Do not inhale or swallow.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep safely out of reach of children. In case of overdose or accidental ingestion, call a poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For adults and children 12 years and older, apply generously and rub on affected area until the cream has penetrated through the skin.
  • Repeat as needed up to 4 times daily.
  • If pain persists or worsens more than seven days, discontinue use and consult a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf extract, arnica montana flower extract, camphor, carbomer, glycerin, isopropyl alcohol, mineral oil, peppermint essential oil, steareth-2, steareth-100, stearyl alcohol, triethanolamine, water.

Questions or comments?

OTC - QUESTIONS SECTION

Toll free 1-800-441-5375, Weekdays, 9 AM to 5 PM (EST)
info@novarnica.com

Distributed by Xcentrik Inc.
Plattsburgh, NY, 12903
© 2017 Xcentrik Inc.
www.novarnica.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

novarnica sport

Pain Relieving
Cream
With natural ingredients

Special formula
for deep penetrating
relief of:

Sports injuries
Sore muscles
Sprains/Strains

113g (4OZ.) NDC 61871-012-15

4 oz (113 g) NDC 61871-012-154 oz (113 g) NDC 61871-012-15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1442261menthol 3 % Topical CreamPSN5
1442261menthol 30 MG/ML Topical CreamSCD5
1442261menthol 3 % Topical CreamSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61871-012-152023-07-28C16284748780-10191ceaa-6ad7-198a-e063-dbdaa90aec3e4c0df2b8-3967-4e9d-969b-0209a48eea31

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61871-012-15Novarnica Sport1 in 1 CARTONCREAM15
61871-012-15Novarnica Sport113 g in 1 BOTTLECREAM1135

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61871-012NOVARNICA SPORT (MENTHOL) CREAM [XCENTRIK INC.]5Legacy NDC, 2 package rows20221221_4c0df2b8-3967-4e9d-969b-0209a48eea31.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61871-01261871-012-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CAMPHOR (NATURAL)N20HL7Q941IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL ALCOHOLND2M416302IACT
MINERAL OILT5L8T28FGPIACT
PEPPERMINT OILAV092KU4JHIACT
STEARETH-2V56DFE46J5IACT
STEARETH-1004OH5W9UM87IACT
STEARYL ALCOHOL2KR89I4H1YIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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
95e4d94f-b7fc-4e46-a12f-b4afd3fdf2f64c0df2b8-3967-4e9d-969b-0209a48eea312022-12-19WarningsExact identifier
spl id: 95e4d94f-b7fc-4e46-a12f-b4afd3fdf2f6
spl set id: 4c0df2b8-3967-4e9d-969b-0209a48eea31

Reported adverse events (FAERS/openFDA)#

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