LEMON AND BASIL 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.

----------

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.

image of 13075leb

LEMON AND BASIL ANTIBACTERIAL FOAMING HAND WASH 
triclosan liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43269-877
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:43269-877-17 517 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 04/22/2013
Labeler - SJ Creations, Inc. (146379495)
Establishment
Name Address ID/FEI Business Operations
Tonic Bath and Body Products Shenzhen Ltd. 528197042 manufacture(43269-877)

Revised: 4/2013
Document Id: 8ef416c4-49ff-4019-89ff-622ac11f7931
Set id: c4a5414c-8aa8-49fc-8d80-0e1ad6e6520e
Version: 1
Effective Time: 20130422
 
SJ Creations, Inc.