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 Type HUMAN OTC DRUG Item Code (Source) NDC:33992-7994
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 1.25 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
ALCOHOL (UNII: 3K9958V90M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:33992-7994-8 227 g in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 07/06/2011
Labeler - Greenbrier International, Inc. (610322518)
Registrant - Ningbo Unichem Household Products Co., Ltd. (528196956)
Establishment
Name Address ID/FEI Business Operations
Ningbo Unichem Household Products Co., Ltd. 528196956 manufacture(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.