HAND CLEANSE - triclosan 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.

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Active Ingredient                                   Purpose

Triclosan 0.15%..................................Antibacterial

Uses

forthe temporary relief of minor aches and pains of muscles and joints.

Keep out of reach of children.�?In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Other information

  • store at 20oC to 25oC (68o to 77oF)

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
  • microwafe
  • 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 worsesn, persists for more than 1 week or tends to recur.

Directions

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

Inactive Ingredients

camphor, carbomer, ethyl alcohol, fd&c blue no.1, isopropyl alcohol, methylchloroisothiazolinone, methylisothiazolinone, sodium hydroxide, water.

label image

HAND CLEANSE 
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-1413
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN0.15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM C14-16 OLEFIN SULFONATE 
SODIUM LAURETH SULFATE 
COCO DIETHANOLAMIDE 
SODIUM CHLORIDE 
PEG-150 DISTEARATE 
CITRIC ACID MONOHYDRATE 
GLYCERIN 
EDETATE DISODIUM 
.ALPHA.-TOCOPHEROL ACETATE 
METHYLCHLOROISOTHIAZOLINONE 
FD&C YELLOW NO. 5 
METHYLISOTHIAZOLINONE 
Packaging
#Item CodePackage Description
1NDC:33992-1413-1444 mL in 1 BOTTLE
2NDC:33992-1413-2592 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E06/22/2013
Labeler - Greenbrier International, Inc. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Pulisi Daily Chemical Products Co., Ltd.529047265manufacture(33992-1413)

Revised: 06/2013
 
Greenbrier International, Inc.