CITRUS BURST ANTIBACTERIAL CLEANSING 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

Aloe Barbadensis, Ammonium Laureth Sulfate, Benzophenone-3, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Deionized Water (aqua), Disodium EDTA, FD and C Red No.40(CI16035), FD and C Yellow No.5 (CI19140), Fragrance (Perfume) Glycerin, Methylchloroisothiazolinone and Methylisothiazolinone, PEG-50 Hydrogenated Castor Oil, Polysorbate 20, Sodium Chloride.

DIST. BY SJ CREATIONS, INC.

P.O. BOX 232428 LEUCADIA, CA 92023, U.S.A.

(888)942-2280 WWW.SJCREATIONSINC.COM

PRODUCT OF CHINA

CITRUS BURST ANTIBACTERIAL CLEANSING HAND WASH
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43269-684
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	2 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
POLYOXYL 50 HYDROGENATED CASTOR OIL (UNII: R07D3A9614)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43269-684-17	514 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/26/2011	05/26/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	05/26/2011	05/26/2013

Labeler - SJ Creations, Inc. (146379495)

Name	Address	ID/FEI	Business Operations
Establishment
Tonic Bath and Body Products Shenzhen Ltd.		528197042	manufacture(43269-684)

Revised: 12/2018

Document Id: 7d5032ec-8503-1e8e-e053-2991aa0aaf64

Set id: 277646f2-3620-4a2d-a27b-ef1797baf4e0

Version: 4

Effective Time: 20181218

SJ Creations, Inc.