Red Apple Antibacterial Hand (Triclosan) Soap [Zhejiang Blue Dream Cosmetics Co., Ltd.] -

RED APPLE ANTIBACTERIAL HAND (TRICLOSAN) SOAP [ZHEJIANG BLUE DREAM COSMETICS CO., LTD.]
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NDC	34460-6001-1
Set ID	4f55bd46-ec4c-43ee-a9c8-9194ded11ad3
Category	HUMAN OTC DRUG LABEL
Packager	Zhejiang Blue Dream Cosmetics Co., Ltd.
Generic Name
Product Class
Product Number
Application Number	PART333A

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ACTIVE INGREDIENT

Active Ingredient

Triclosan 0.115%
PURPOSE

Purpose:

Antibacteria
INDICATIONS & USAGE

Uses:

For hand washing to decrease bacteria on skin
WARNINGS

Warnings:

For external use only

When using this product, avoid contact with eyes. In case of contact, flush with water
KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION

Directions:

    * Wet hands
    * Apply small amount to hands
    * Scrub thoroughly
    * Rinse
    * For children under 6, use only under adult supervision.
INACTIVE INGREDIENT

Inactive Ingredient:

Water (aqua), Sodium Laureth Sulfate, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Decyl Glucoside, Cocamide DEA, Fragrance (Parfum), DMDM Hydantoin, Citric Acid, Disodium EDTA, FD and C Red No. 40
PRINCIPAL DISPLAY PANEL

label

INGREDIENTS AND APPEARANCE

RED APPLE ANTIBACTERIAL HAND
triclosan soap

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	0.115 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	84.034 g in 100 g
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)	2.1 g in 100 g
SODIUM LAURYL SULFATE (UNII: 368GB5141J)	2.5 g in 100 g
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)	2.5 g in 100 g
SODIUM CHLORIDE (UNII: 451W47IQ8X)	2.0 g in 100 g
COCO DIETHANOLAMIDE (UNII: 92005F972D)	1.5 g in 100 g
DMDM HYDANTOIN (UNII: BYR0546TOW)	1.3 g in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	1.1 g in 100 g
EDETATE DISODIUM (UNII: 7FLD91C86K)	1.25 g in 100 g
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.001 g in 100 g
APPLE (UNII: B423VGH5S9)	0.3 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:34460-6001-1	265 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/07/2010

Labeler - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)

Registrant - Zhejiang Blue Dream Cosmetics Co., Ltd. (529047234)

Name	Address	ID/FEI	Business Operations
Establishment
Zhejiang Blue Dream Cosmetics Co., Ltd.		529047234	manufacture

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