MANDARIN NECTAR ANTIBACTERIAL FOAMING HANDWASH- 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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MANDARIN NECTAR ANTIBACTERIAL FOAMING HAND WASH

Active Ingredient Purpose

Triclosan 0.2%............................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 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.

Marketed by SJ Creations, Inc.

Leucadia, CA 92024

MANUFACTURED IN CHINA

www.sjcreationsinc.com

mandarindrugfactspanel

Mandarin Nectar

Antibacterial Foaming Hand Wash

17.5 OZ (517 ml)

mandarinPDP

MANDARIN NECTAR ANTIBACTERIAL FOAMING HANDWASH
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43269-618
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43269-618-17	517 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/23/2010	06/23/2012

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/23/2010	06/23/2012

Labeler - SJ Creations, Inc. (146379495)

Name	Address	ID/FEI	Business Operations
Establishment
Tonic Bath And Body Products Shenzhen Ltd		528197042	manufacture(43269-618)

Revised: 12/2018

Document Id: 7d67ee0b-5ef9-914c-e053-2a91aa0abb0c

Set id: aa4827c9-0f94-403f-a3ec-e45bca2c19a1

Version: 2

Effective Time: 20181219

SJ Creations, Inc.