Novarnica
FDA Label NDC 61871-001

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 (NDC 61871-001). 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, other information, inactive ingredients, questions?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Camphor 4%
Menthol 8%

Purpose

Topical Analgesic

Uses

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains

Warnings

  • For external use only
  • Avoid contact with eyes and mucous membranes
  • Do not apply on wounds or damaged skin
  • Do not bandage tightly
  • Do not apply external heat such as an electric heating pad, as this may result in excessive skin irritation or skin burn
  • Do not apply on or near the nipple
  • If pregnant or breastfeeding, ask a health professional before use
  • Do not inhale or swallow
  • Allergy Alert: Do not use if allergic to Asteraceae/Compositae/Daisy family or to any other ingredient contained in this product
  • Flammable: Keep away from fire or flame

  • When using this product Rashes and/or burning discomfort have been known to occur; in which case discontinue use. Stop use and ask a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days.

Directions

  • Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 12 years of age: consult a physician.

Other Information

  • Shake well before usage
  • Simply spray solution on affected body part and let penetrate through skin, no rubbing necessary
  • Storage information: Store at room temperature;
  • Close cap tightly after use

Inactive Ingredients

Arnica Montana flower extract, clove essential oil, eucalyptus essential oil, isopropyl alcohol, peppermint essential oil, polysorbate 20, purified water

Questions?

If you have questions of a medical nature, please contact your pharmacist, doctor or health care professional

Xcentrik Inc.
7902 Samuel Hatt
Chambly (Quebec) Canada J3L 6W4
1-800-441-5375
www.novarnica.com
Made in Canada

Principal Display Panel

novarnica

Pain Relieving Spray
With natural ingredients

Simple
Backache
Arthritis
Strains
Bruises
Sprains

Spray solution
No rubbing
Fast acting

2.19 FL OZ (65 ml)

2.19 Fl Oz (65 mL) (Novarnica 65ml)

2.19 Fl Oz (65 mL) (Novarnica 65ml)

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