LUXURY ANTIBACTERIAL FOAMING- tricolsan soap
RD Food Service DBA Restaurant Depot

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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Luxury Antibacterial Foaming Hand Soap

Active Ingredient

Triclosan 0.6%

Luxury Antibacterial Foaming Hand Soap

Uses

Antibacterial hand cleaner.
Use in a variet of public facilities including daycare centers, hospitals, nursing homes, physicians offices.

Luxury Antibacterial Foaming Hand Soap

Warnings

For external use only.
Avoid contact with eyes.
Children under the age of 6 should be supervised by an adult when using this product.
Discontinue use is irritation or redness develops.
If irritation persists for more than 72 hours, consult a physician.
KEEP OUT OF REACH OF CHILDREN.

Luxury Antibacterial Foaming Hand Soap

Directions

Read the entire label before using this product.
Dispense 1-2 pumps of product onto wet aplms.
lather and rinse hands with clean water.

Luxury Antibacterial Foaming Hand Soap

Inactive Ingredients

Water, Sodium Laureth Sulfate, Sodium Laurel Sulfate, Alcohol, Cocamidopropyl Betaine, Sodium Lauroyl Sarcosinate, Glycerine, Coco Monoethanolamide, DMDM Hydantoin, Citric Acic Monohydrate, Edate Sodium, Iodopropanyl Butylcabamate, Aloe Barbadensis Leaf Juice, FD&C Blue #1.

Luxury Antibacterial Foaming Hand Soap

Purpose

Antibacterial

Luxury Antibacterial Foaming Hand Soap

KEEP OUT OF REACH OF CHILDREN

Luxury Antibacterial Foaming Hand Soap

RD_759

RD 759

LUXURY ANTIBACTERIAL FOAMING
tricolsan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:56131-759
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	6 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
ALCOHOL (UNII: 3K9958V90M)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE SODIUM (UNII: MP1J8420LU)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:56131-759-29	1000 mL in 1 BAG; Type 0: Not a Combination Product	04/30/2013	04/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	04/30/2013	04/01/2019

Labeler - RD Food Service DBA Restaurant Depot (878186774)

Registrant - Betco corporation, Ltd. (005050158)

Name	Address	ID/FEI	Business Operations
Establishment
Betco Corpo, Ltd.		005050158	manufacture(56131-759) , pack(56131-759) , label(56131-759)

Revised: 4/2019

Document Id: 8640dab4-4e73-d636-e053-2991aa0a16d8

Set id: 35ed2772-d826-4284-8213-8d5d7b784af7

Version: 3

Effective Time: 20190411

RD Food Service DBA Restaurant Depot