RED APPLE ANTIBACTERIAL HAND- triclosan soap

Red Apple Antibacterial Hand by

Drug Labeling and Warnings

Red Apple Antibacterial Hand by is a Otc medication manufactured, distributed, or labeled by Zhejiang Blue Dream Cosmetics Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

Inactive Ingredients
Ingredient Name	Strength
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

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

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

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

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

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