Drug Fact

HEALING WATERS CUCUMBER MINT ANTIBACTERIAL HAND SOAP - triclosan liquid
Taizhou Xinzhixuan Daily-Use 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.

----------

Drug Fact

Active Ingredients Purpose
Triclosan 0.115% Antibacterial

Uses

For hand washing to decrease bacteria on skin

Warnings

For external use only-hands. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately

Directions

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

Inactive Ingredients

water(Aqua), Sodium Laureth Sulfate, Cocamide DEA, Disodium EDTA, Citric Acid, Methylchloroisothiazolinone, Fragrance, Methylisothiazolinone, Sodium Chloride. May contain: FD and C Red No. 40, FD and C Yellow No. 5, FD and C Blue No. 1

labe

HEALING WATERS CUCUMBER MINT ANTIBACTERIAL HAND SOAP
triclosan liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:50593-002
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)	80.97499 g in 100 g
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)	12.0 g in 100 g
COCAMIDE DIETHANOLAMINE (UNII: 92005F972D)	5.0 g in 100 g
EDETATE DISODIUM (UNII: 7FLD91C86K)	0.08 g in 100 g
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.15 g in 100 g
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)	0.04 g in 100 g
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)	0.04 g in 100 g
SODIUM CHLORIDE (UNII: 451W47IQ8X)	1.2 g in 100 g
FD&C RED NO. 40 (UNII: WZB9127XOA)	0.000002 g in 100 g
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)	0.000004 g in 100 g
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)	0.000004 g in 100 g
CUCUMBER (UNII: YY7C30VXJT)	0.2 g in 100 g
MINT (UNII: FV98Z8GITP)	0.2 g in 100 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:50593-002-01	480 g in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333	02/10/2010

Labeler - Taizhou Xinzhixuan Daily-Use Co., Ltd. (420438920)

Registrant - Taizhou Xinzhixuan Daily-Use Co., Ltd. (420438920)

Name	Address	ID/FEI	Business Operations
Establishment
Taizhou Xinzhixuan Daily-Use Co., Ltd.		420438920	manufacture