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Assured Ice Cold Topical Analgesic

Dosage form: gel
Ingredients: CAMPHOR (SYNTHETIC) 3.0g in 100g, MENTHOL 1.25g in 100g
Labeler: Greenbrier International, Inc.
NDC Code: 33992-7993

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

Active Ingredients

Camphor 3.0%

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

carbomer, 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 
camphor, menthol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-7993
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)3.0 g  in 100 g
MENTHOL (MENTHOL) MENTHOL1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FD&C BLUE NO. 1 
ISOPROPYL ALCOHOL 
METHYLCHLOROISOTHIAZOLINONE 
SODIUM HYDROXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:33992-7993-8227 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)

Revised: 07/2011
 
Greenbrier International, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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