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ASSURED ICE COLD TOPICAL ANALGESIC

Medically reviewed on Mar 27, 2018

Dosage form: gel
Ingredients: MENTHOL 1.25g in 100g
Labeler: Greenbrier International, Inc.
NDC Code: 33992-7994

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

  • 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.

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)

ASSURED ICE COLD TOPICAL ANALGESIC  
menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
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/FEIOperations
Ningbo Unichem Household Products Co., Ltd.528196956manufacture(33992-7994)

 
Greenbrier International, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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