SIMPLE PLEASURES ANTIBACTERIAL HAND- triclosan soap

simple pleasures by

Drug Labeling and Warnings

simple pleasures by is a Otc medication manufactured, distributed, or labeled by Tri-Coastal Design Company Inc. , Guangzhou St Eva Fine Chemical Co Ltd . Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Triclosan 0.3%

Purpose

Antiseptic

Uses

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

Warnings

• For external use only
• Flammable, keep away from fire and flame
• Does not contain grain alcohol; do not drink.

If taken internally will produce serious gastric disturbances

When using this product

• Avoid the eyes and mucous membranes
• In the case of eye or mucous membrane contact; rinse area thoroughly with water

Stop use and ask a doctor if

• condition worsens
• redness or irritation develops
• condition persists for more than 3 days

Keep out of reach of children

If swallowed contact a doctor or Poison Control Center immediately.

Directions

• Wet hands, work into a lather. Rinse well
• Supervise children in the use of this product
• In the case of eye contact, rinse eyes thoroughly with water

Other information

• Store below 105F
• May discolor some fabrics

Inactive Ingredients

Benzophenone-4, Citric Acid, Cocamidopropyl Betaine, Cocamide DEA, DC Red 33, Disodium EDTA, FDC Red 40, Fragrance (Parfum), Methylchloroisothiazolinone, Methylisothiazolinone, PEG-150 Distearate, Sodium Laureth Sulfate, Water (Aqua)

Package Label

INGREDIENTS AND APPEARANCE

SIMPLE PLEASURES  ANTIBACTERIAL HAND
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49852-174
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZOPHENONE (UNII: 701M4TTV9O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49852-174-08	250 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/21/2012

Labeler - Tri-Coastal Design Company Inc. (609734900)

Establishment
Name	Address	ID/FEI	Business Operations
Guangzhou St Eva Fine Chemical Co Ltd		528039793	manufacture(49852-174)