LUCKY ANTIBACTERIAL HAND SOAP SUPERSOFT- triclosan liquid

Lucky Antibacterial Hand Soap by

Drug Labeling and Warnings

Lucky Antibacterial Hand Soap by is a Otc medication manufactured, distributed, or labeled by Delta Brands Inc, Ningbo Pulisi Daily Chemical Co. Ltd., Delta Dis Ticaret A.S., Primo Ambalaj ve Kimya Sanayi ve Ticaret A S , Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil, Marmara Temizlik Maddeleri Sanayi Ve Ticaret Ltd STI. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Triclosan 0.1%

Purpose

Antibacterial

Uses

For handwashing to decrease bacteria on the skin. Recommended for repeated use.

Warnings

For external use only

When using this product

avoid contact with eyes. In case of eye contact immediately flush eyes with water, call a doctor. Avoid contact with broken skin.
Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

Keep out of reach of children

Children can only use this product with adult supervision. Do not drink. Not edible. In case of accidental ingestion seek professional assistance or contact Poison Control Center immediately.

Directions

Wet hands. Apply palmful to hands. Scrub thoroughly. Rinse. Recommended for repeated use

INACTIVE INGREDIENT

Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, Cocamide DEA, Polyquaternium-7, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Tetrasodium EDTA, Benzophenone-4, Citric Acid, Alphatocopherol Acetate (Vitamin E), FDC Yellow No. 6, FDC Yellow No. 5, DC Red No. 33,

PRINCIPAL DISPLAY PANEL

Package Label

INGREDIENTS AND APPEARANCE

LUCKY ANTIBACTERIAL HAND SOAP  SUPERSOFT
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20276-163
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.1 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 900 KD) (UNII: B70CUU14M9)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
EDETATE SODIUM (UNII: MP1J8420LU)
BENZOPHENONE (UNII: 701M4TTV9O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20276-163-75	222 mL in 1 BOTTLE, SPRAY
2	NDC: 20276-163-08	237 mL in 1 BOTTLE, PUMP
3	NDC: 20276-163-09	266 mL in 1 BOTTLE, PUMP
4	NDC: 20276-163-10	296 mL in 1 BOTTLE, PUMP
5	NDC: 20276-163-11	333 mL in 1 BOTTLE, PUMP
6	NDC: 20276-163-12	355 mL in 1 BOTTLE, PUMP
7	NDC: 20276-163-13	400 mL in 1 BOTTLE, PUMP
8	NDC: 20276-163-14	414 mL in 1 BOTTLE, PUMP
9	NDC: 20276-163-15	444 mL in 1 BOTTLE, PUMP
10	NDC: 20276-163-16	500 mL in 1 BOTTLE, PUMP
11	NDC: 20276-163-32	946 mL in 1 BOTTLE, PLASTIC
12	NDC: 20276-163-40	1183 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333	09/01/2010

Labeler - Delta Brands Inc (102672008)

Establishment
Name	Address	ID/FEI	Business Operations
Ningbo Pulisi Daily Chemical Co. Ltd.		529047265	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Delta Dis Ticaret A.S.		643703853	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Primo Ambalaj ve Kimya Sanayi ve Ticaret A S		356694526	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil		566220234	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Marmara Temizlik Maddeleri Sanayi Ve Ticaret Ltd STI		356082250	manufacture