NOVARNICA- camphor and menthol spray

Novarnica by

Drug Labeling and Warnings

Novarnica by is a Otc medication manufactured, distributed, or labeled by Xcentrik Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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.

• Keep safely out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

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)

PRINCIPAL DISPLAY PANEL

4.06 FL OZ (120 ml)

INGREDIENTS AND APPEARANCE

NOVARNICA 
camphor and menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61871-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	4 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	8 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CLOVE OIL (UNII: 578389D6D0)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
PEPPERMINT OIL (UNII: AV092KU4JH)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61871-001-01	1 in 1 CARTON	01/22/2014
1		65 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 61871-001-02	1 in 1 CARTON	01/22/2014
2		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part348	01/22/2014

Labeler - Xcentrik Inc. (206906492)