FRESH HERBS ANTIBACTERIAL FOAMING HAND WASH - triclosan liquid 
SJ Creations, 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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Drug Facts

Active Ingredient

Triclosan 0.2% (Purpose: Antiseptic)

Uses

For handwashing to decrease bacteria on the skin.

Warnings

For external use only.


When using this product

Avoid contact with eyes. If contact occurs flush eyes with water.

Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.


Keep out of the reach of Children

If swallowed get medical help or contact a Poison Control Center right away.

Directions

Wet hands. Apply palmful to hands and forearms. Scrub thoroughly. Rinse and repeat. Dry thoroughly.

Inactive Ingredients

Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Deionized Water (aqua), Disodium EDTA, Fragrance (Perfume) Glycerin, Methylchloroisothiazolinone and Methylisothiazolinone, Polysorbate 20, Sodium Laureth Sulfate.

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FRESH HERBS ANTIBACTERIAL FOAMING HAND WASH 
triclosan liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43269-841
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN 2 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
COCO DIETHANOLAMIDE (UNII: 92005F972D)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
OXYBENZONE (UNII: 95OOS7VE0Y)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:43269-841-16 500 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333E 10/03/2012
Labeler - SJ Creations, Inc. (146379495)
Establishment
Name Address ID/FEI Business Operations
Tonic Bath and Body Products Shenzhen Ltd. 528197042 manufacture(43269-841)

Revised: 10/2012
Document Id: 5efc7460-9361-4fcb-bb9a-7914c86f220e
Set id: 3fc48811-7ea1-4b2f-b8ca-f65c61087b8d
Version: 1
Effective Time: 20121003
 
SJ Creations, Inc.