Your browser does not support JavaScript! ANTIBACTERIAL HAND (TRICLOSAN) SOAP [GREENBRIER INTERNATIONAL, INC.]
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RxNorm Names

ANTIBACTERIAL HAND (triclosan) soap
[Greenbrier International, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Antibacterial Hand Soap


Active Ingredient

Triclosan 0.15%

Purpose

Antibacterial

Uses

For hand washing to decrease bacteria on the skin.

Warnings

For external use only.

When using this product avoid contact with eyes. In case of contact, flush with water.

Stop use and ask a doctor if irritation and redness develops.

Keep out of reach of children if swallowed, get medical help or contact a poison control center right away.

Directions

  • pump into hands
  • lather vigorously for at least 15 seconds
  • rinse and dry thoroughly

Other Information

  • store at room temperature

Inactive Ingredients

water, sodium c14-16 olefin sulfonate, sodium laureth sulfate, cocamide DEA, sodium chloride, PEG-150 distearate, fragrance, citric acid, glycerin, disodium EDTA, tocopheryl acetate, methylchloroisothiazolinone, fd c yellow no.5, methylisothiazolinone.

Antibacterial Hand Soap 16oz/500ml (33992-0100-0)

HandSoap

ANTIBACTERIAL HAND 
triclosan soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-0100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TRICLOSAN (TRICLOSAN) TRICLOSAN1.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
SODIUM C14 OLEFIN SULFONATE 
SODIUM LAURETH-3 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:33992-0100-0500 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333E12/05/2012
Labeler - Greenbrier International, Inc. (610322518)
Registrant - Ningbo Unichem Household Products Co., Ltd. (528196956)
Establishment
NameAddressID/FEIBusiness Operations
Ningbo Unichem Household Products Co., Ltd.528196956manufacture(33992-0100)

Revised: 12/2012
Document Id: 04aead72-c449-4fef-bd39-d56ed1037166
Set id: 3f8e5cd1-8c16-4f73-a796-85e741a6fb67
Version: 1
Effective Time: 20121205
 
Greenbrier International, Inc.

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