ASSURED ICE COLD TOPICAL ANALGESIC- menthol gel

ASSURED ICE COLD TOPICAL ANALGESIC by

Drug Labeling and Warnings

ASSURED ICE COLD TOPICAL ANALGESIC by is a Otc medication manufactured, distributed, or labeled by Greenbrier International, Inc., Ningbo Unichem Household Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• smoking
• excessive phlegm
• asthma
• emphysema
• persistent or chronic cough
  

When using this product do not

• heat
• microwave
• add to hot water or any container where healing water may cause splattering and result in burns
• use in eyes or directly on mucous membranes
• take by mouth or place in nostrils
• apply to wounds or damaged skin
• bandage skin
  

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

• see important warnings under "When using this product"
• adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily
• children under 2 years of age: consult a physician.
  

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.

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

ASSURED ICE COLD TOPICAL ANALGESIC  
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 33992-7994
Route of Administration	TOPICAL

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)