ASSURED ICE COLD TOPICAL ANALGESIC  - menthol gel 
Greenbrier International, 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.

----------

ASSURED ICE COLD TOPICAL ANALGESIC GEL

ASSURED ICE COLD TOPICAL ANALGESIC GEL


Active Ingredient

Menthol 1.25%

Purpose

Topical Analgesic

Uses

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

Warnings


For external use only. Avoid contact with eyes.

Ask a doctor before use if you have cough associated with

When using this product do not

Consult a doctor and discontinue use

if condition worsens, persist for more than 1 week or tends to recur

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Other information

store at 20 to 25 degreesC (68 to 77degrees F)


Inactive Ingredients

camphor, carbomer, ethyl alcohol, FDandC blue no.1, isopropyl alcohol, methylchloroisothiasolinone, methylisothiazolinone, sodium hydroxide, water.

Assured ICE COLD

Topical Analgesic Gel

Net wt 8oz (227g)



DISTRIBUTED BY:

GREENBRIER INTERNATIONAL, INC.

CHESAPEAKE, VA 23320

MADE IN CHINA

ASSURED ICE COLD TOPICAL ANALGESIC GEL 8oz (33992-7994-8)

ICECOLD

ASSURED ICE COLD TOPICAL ANALGESIC  
menthol gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:33992-7994
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (MENTHOL) MENTHOL1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (NATURAL) 
ALCOHOL 
FD&C BLUE NO. 1 
ISOPROPYL ALCOHOL 
METHYLCHLOROISOTHIAZOLINONE 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-7994-8227 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/06/2011
Labeler - Greenbrier International, Inc. (610322518)
Registrant - Ningbo Unichem Household Products Co., Ltd. (528196956)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Unichem Household Products Co., Ltd.528196956manufacture(33992-7994)

Revised: 3/2013
Document Id: 60d86534-5a3e-4e06-ad00-f9a2aaed181c
Set id: d5ed7b8e-0f51-46dc-b35f-52d28d8dff10
Version: 4
Effective Time: 20130327
 
Greenbrier International, Inc.