Novarnica Sport
FDA Label NDC 61871-012

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Xcentrik Inc. for the product Novarnica Sport (NDC 61871-012). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, directions, inactive ingredients, questions or comments?, principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 3%

Purpose

Topical Analgesic

Uses

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

Warnings

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.

Directions

  • 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

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?

Toll free 1-800-441-5375, Weekdays, 9 AM to 5 PM (EST)
[email protected]

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

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 61871-012-15 (Novarnica 113g)

4 Oz (113 G) Ndc 61871-012-15 (Novarnica 113g)

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