4c0df2b8-3967-4e9d-969b-0209a48eea31

SPL v5
SPL
SPL Set ID 4c0df2b8-3967-4e9d-969b-0209a48eea31
Route
topical
Published
Effective Date 2019-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (3 g)
Inactive Ingredients
aloe vera leaf arnica montana flower camphor (natural) carbomer homopolymer type c (allyl pentaerythritol crosslinked) glycerin isopropyl alcohol mineral oil peppermint oil steareth-2 steareth-100 stearyl alcohol trolamine water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2019-03-01

Purpose

Topical Analgesic

Description

Drug Facts


Medication Information

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.
Uses

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

Purpose

Topical Analgesic

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.

Description

Drug Facts

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

Section 42229-5

Drug Facts

Section 50565-1
  • Keep safely out of reach of children. In case of overdose or accidental ingestion, call a poison control center immediately.
Active Ingredients

Menthol 3%

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


Structured Label Content

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.
Uses

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

Purpose

Topical Analgesic

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 (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.

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep safely out of reach of children. In case of overdose or accidental ingestion, call a poison control center immediately.
Active Ingredients (Active ingredients)

Menthol 3%

Questions Or Comments? (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


Advanced Ingredient Data


Raw Label Data

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