NOVARNICA MOISTURIZING FOOT CREAM- menthol cream
Xcentrik Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Menthol 3%

Purpose

Topical Analgesic

Uses

For fast and soothing relief of foot pain, dry itchy skin and rough cracking heels. Moisturizes and revitalizes from ankles to toes.

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 breastfeeding.
Do not inhale or swallow.

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

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, methylchloroisothiazolinone, methylisothiazolinone, methylparaben, mineral oil, peppermint essential oil, sodium benzoate, steareth-2, steareth-100, stearyl alcohol, triethanolamine, water.

Questions or comments?

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

Distributed by Xcentrik Inc.
7902 Samuel Hatt
Chambly (Quebec) Canada J3L 6W4
www.novarnica.com

Principal Display Panel

novarnica

Moisturizing
FOOT RELIEF CREAM
WITH NATURAL INGREDIENTS
Aloe & Arnica Montana

Fast and soothing relief of:

Foot Pain
Extreme Dryness
Roughness
Itching
Cracking
Flaking
Hardening

Fast acting
Non greasy
Cools & soothes quickly
Also for diabetics

NET WT. 4 OZ (113g.) NDC 61871-010-10
4 oz (113 g) NDC 61871-010-10

NOVARNICA MOISTURIZING FOOT CREAM
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:61871-010
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	3 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-100 (UNII: 4OH5W9UM87)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:61871-010-10	1 in 1 CARTON	04/01/2015	03/31/2018
1		113 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part348	04/01/2015	03/31/2018

Labeler - Xcentrik Inc. (206906492)

Revised: 1/2019

Document Id: 4aec158b-5161-4739-be43-433ece246787

Set id: dff56806-16bc-49bd-9412-399257c56903

Version: 4

Effective Time: 20190109

Xcentrik Inc.