RxNorm Names

Review RxNorm Normal Forms

FAST FREEZE (menthol) gel
[Natural Essentials Inc.]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=a96e3e41-871c-4cf3-93b6-af2a6246ded8

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph not final

NOTE: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.

Drug Label Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

Drug Facts

Active ingredients

Menthol 3.5%

Purpose

Cooling Pain Relief

Uses

Temporary relief of minor aches and pains of muscles and joints associated with:

Simple backache
Arthritis
Strains
Sprains

Warnings

For external use only
Flammable
Keep away from excessive heat or open flame

Do not use

With heating pad or device
With ointments, creams, sprays or liniments
On wounds, damaged skin or irritated skin

Ask a doctor before use if you

Have sensitive skin
Are pregnant or breastfeeding

When using this product

Avoid contact with eyes or mucous membranes
Do not bandage tightly

Stop use and ask a doctor if

Condition worsens
Symptoms persist for more than 7 days or clear up then reoccur again within a few days
Irritation develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults/Children 2 years and older:

Roll on the affected area not more than 3 to 4 times daily
Shake well before use

Children under 2 years old: Consult a physician.

Other information

Replace cap after use
Store in a cool, dry place

Inactive ingredients

Aloe Barbadensis (Aloe Vera) Leaf Extract, Carbomer, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Methylparaben, Tocopherol (Vitamin E) Acetate, Triethanolamine, Water.

Questions?

Call 317-228-1144 or visit www.Bell-Horn.com or www.fastfreeze.com

Principal Display Panel – Bottle Label

FAST FREEZE®

Naturally
Cool

Pain Relieving Roll-On

Helps to relieve

Sore muscles
Strains & sprains
Joint pain

………………………………….

Invigorating cooling menthol
Greaseless & stain-free
Natural ingredients include
Vitamin E, Aloe & llex

………………………………….

3 oz (89 mL)

FAST FREEZE
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66902-016
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (MENTHOL)	MENTHOL	35 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
ILEX PARAGUARIENSIS LEAF
ISOPROPYL ALCOHOL
METHYLPARABEN
.ALPHA.-TOCOPHEROL ACETATE
TROLAMINE
WATER

Packaging
#	Item Code	Package Description
1	NDC:66902-016-05	1 g in 1 PACKET
2	NDC:66902-016-03	1 g in 1 BOTTLE
3	NDC:66902-016-04	1 g in 1 TUBE
4	NDC:66902-016-16	1 g in 1 BOTTLE, PUMP
5	NDC:66902-016-32	1 g in 1 BOTTLE, PUMP
6	NDC:66902-016-01	1 g in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/01/2013

Labeler - Natural Essentials Inc. (947484713)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Essentials Inc.		947484713	MANUFACTURE(66902-016)

Revised: 12/2012

Document Id: f78e1578-1fb0-4096-b299-64d661f911a9

Set id: a96e3e41-871c-4cf3-93b6-af2a6246ded8

Version: 1

Effective Time: 20121231

Natural Essentials Inc.

Daily Med

Current Medication Information

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