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NanoFreeze

Concept Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

NanoFreeze™


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

Active ingredient Purpose
Menthol 12% Pain Relieving
Camphor 6% Pain Relieving

Uses

for the temporary relief of minor aches and pains of muscles and joints associated with

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

For external use only.

  • do not apply to wounds or damaged skin
  • do not bandage tightly

When using this product do not get into eyes

  • avoid contact with other mucous membranes

Extremely Flammable: Keep from heat and flame.

Discontinue 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 out of reach of children.

  • if swallowed, get medical help or contact a Poison Control center right away
  • if pregnant or nursing, seek the advice of a health professional before using

Directions

  • Rotate sprayer's black locking mechanism counter-clockwise to unlock; clockwise to lock. Lock sprayer when not in use.
  • Children under 12 years of age consult a physician
  • Sprayer will need to be primed before initial use. Squeeze trigger pointed away from face several times until liquid dispenses. Sprayer can dispense at a 180˚ angle, but will need to be re-primed periodically
  • Spray liberally to affected area not more than 3 to 4 times daily
  • Wash hands with soap and water after each application to avoid spreading to the eyes or other sensitive mucous membranes

Inactive ingredients

SD Alcohol 40-B, Water (Aqua), Aloe Barbadensis Leaf Juice, Acrylates Copolymer, Polysorbate 20, Mentha Piperita (Peppermint) Oil, Arnica Montana Flower Extract, Linum Usitatissmum (Linseed) Seed Oil, Euterpe Oleracea Fruit Oil, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Methyl Diisopropyl Propionamide, Ethyl Methane Carboximide, Methyl Lactate, Lauryl Laurate, Zea Mays (Corn) Starch, Hydrolyzed Corn Starch, Hydrolyzed Starch Octenylsuccinate.

Distributed by:
KeyView Labs, Inc.
St Petersburg, Fl

Manufactured by:
Concept Laboratories, Inc.
Chicago, IL 60642 (USA)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

nanofreeze™

targeted pain relief spray

NDC 64058-147-64

PAIN RELIEVING TOPICAL
ANALGESIC WITH

  • menthol & camphor
  • powerful omegas 3s
  • acai extract
  • no-rub spray for
    hard to reach areas
  • fast-acting
    time-release

IcePearls

4 FL OZ (118mL)

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

NanoFreeze

Menthol and Camphor (Synthetic) SPRAY

Product Information

Product Type Human otc drug label Item Code (Source) NDC:64058-147
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
MENTHOL 14.16 g
CAMPHOR (SYNTHETIC) 7.08 g

Inactive Ingredients

Ingredient Name Strength
water
Aloe Vera Leaf
ARNICA MONTANA FLOWER
POLYSORBATE 20
METHYL DIISOPROPYL PROPIONAMIDE
LAURYL LAURATE
PEPPERMINT OIL
ALCOHOL
LINSEED OIL
ROSEMARY OIL
ACAI OIL
PPG-2 HYDROXYETHYL COCAMIDE
STARCH, CORN
METHYL LACTATE, L-

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:64058-147-64 118 in 1 BOTTLE, SPRAY

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2013-10-14


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