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 should 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

Deionized Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine,Sodium Chloride, Cocamide DEA, Glycerin*, Polyquaternium-7*, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone, Citric Acid, Benzophenone-4, FDC Yellow No. 6, DC Red No 33
*May contain one or more of these ingredients

Product Label

ANTIBACTERIAL HAND SOAP
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:20276-165
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)

#	Item Code	Package Description
Packaging
1	NDC:20276-165-75	221 mL in 1 BOTTLE, PUMP
2	NDC:20276-165-08	237 mL in 1 BOTTLE, PUMP
3	NDC:20276-165-09	266 mL in 1 BOTTLE, PUMP
4	NDC:20276-165-10	296 mL in 1 BOTTLE, PUMP
5	NDC:20276-165-11	325 mL in 1 BOTTLE, PUMP
6	NDC:20276-165-12	355 mL in 1 BOTTLE, PUMP
7	NDC:20276-165-13	384 mL in 1 BOTTLE, PUMP
8	NDC:20276-165-35	400 mL in 1 BOTTLE, PUMP
9	NDC:20276-165-14	414 mL in 1 BOTTLE, PLASTIC
10	NDC:20276-165-15	444 mL in 1 BOTTLE, PLASTIC
11	NDC:20276-165-16	500 mL in 1 BOTTLE, PUMP
12	NDC:20276-165-20	592 mL in 1 BOTTLE, PLASTIC
13	NDC:20276-165-24	710 mL in 1 BOTTLE, PLASTIC
14	NDC:20276-165-32	946 mL in 1 BOTTLE, PLASTIC
15	NDC:20276-165-33	1000 mL in 1 BOTTLE, PLASTIC
16	NDC:20276-165-48	1420 mL in 1 BOTTLE, PLASTIC
17	NDC:20276-165-64	1890 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/30/2011

Labeler - Delta Brands Inc (102672008)

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

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

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

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

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