POWERHOUSE FRESH SCENT ULTRA DISH - triclosan soap
Personal Care Products

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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Powerhouse Fresh Scent Ultra Dish

Active Ingredient

Triclosan 0.10%

Purpose

Antibacterial Hand Soap

Keep out of reach of children

In case of accidental ingestion, drink a glass of water to dilute. If eye contact occurs, rinse thoroughly with water.

Use

Helps fights germs on hands when used as a hand soap.

Warning

For external use only

Directions

Wash hands and rinse.

Inactive Ingredients:

Powerhouse Fresh Scent Ultra Dish Detergent Antibacterial Hand Soap

19 fl oz.

(1 pt.3 oz) 562 ml

POWERHOUSE FRESH SCENT ULTRA DISH
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:29500-9087
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	.562 mL in 562 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:29500-9087-2	562 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/19/2011

Labeler - Personal Care Products (966155082)

Name	Address	ID/FEI	Business Operations
Establishment
Ningbo Unichem Household Products Co Ltd		528196956	manufacture

Revised: 12/2011

Document Id: b635599f-bbdc-4b33-ae77-9d4b761669b8

Set id: b50ff44e-784f-4478-9f1e-01cf21f0c926

Version: 1

Effective Time: 20111229

Personal Care Products