DRUG FACT

RED APPLE ANTIBACTERIAL HAND - triclosan soap
Zhejiang Blue Dream Cosmetics Co., Ltd.

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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DRUG FACT

Active Ingredient

Triclosan 0.115%

Purpose:

Antibacteria

Uses:

For hand washing to decrease bacteria on skin

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, except under adult supervision. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

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

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

label label

RED APPLE ANTIBACTERIAL HAND
triclosan soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:34460-6001
Route of Administration	TOPICAL

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