ANTIBACTERIAL HAND - triclosan soap 
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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Antibacterial Hand Soap

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

Other Information

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 Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 1.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM C14 OLEFIN SULFONATE (UNII: N816E2SOKI)  
SODIUM LAURETH-3 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 Code Package Description Marketing Start Date Marketing End Date
1 NDC:33992-0100-0 500 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333E 12/05/2012
Labeler - Greenbrier International, Inc. (610322518)
Registrant - Ningbo Unichem Household Products Co., Ltd. (528196956)
Establishment
Name Address ID/FEI Business Operations
Ningbo Unichem Household Products Co., Ltd. 528196956 manufacture(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.