HAND CLEANSE REFILL- 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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Hand Cleanse

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

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

Directions

Inactive Ingredients

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

label image

HAND CLEANSE  REFILL
triclosan gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-3008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN7.5 mg  in 500 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:33992-3008-1500 mg in 1 BOTTLE; Type 0: Not a Combination Product05/24/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E05/24/2013
Labeler - Greenbrier International, Inc. (610322518)
Establishment
NameAddressID/FEIBusiness Operations
China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(33992-3008)

Revised: 4/2019
Document Id: 86a76a38-a58b-2f29-e053-2991aa0a5227
Set id: 96c76105-a782-4343-90b6-1d6f6770f3fa
Version: 4
Effective Time: 20190416
 
Greenbrier International, Inc.