SPATHERAPY  - benzalkonium chloride lotion 
Xiamen Olivee Daily Use Chemical 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 Facts

Inactive Ingredients - Water, Sodium Laureth

Sulfate, Cocamidopropyl Betaine, Glycerin, DMDM

Hydantoin, Benalkonium Clhoride, Fragrance,

Xanthan Gum, Disodium EDTA,

Citiric Acid. May contain: CI 14700, CI 17200, CI 19140, Ci 42090

Active Ingredient

Benzalkonium Chloride  0,2 %

Purpose

Antibacterial

Use - handwashing to decrease bacteria on skin

Directions - wet hands, work into

rich lather - rinse well

Warnings

For external use only

When using this product, avoid contact with eyes. If contact occurs,

rinse thoroughly with water.

Stop use and ask a doctor if irritation and redness develop

EKeep out of reach of children. If swallowed, get medical help

or contact a Poison Control Center right away.

Questions? 1-800-FDA-1088

copy of label

SPATHERAPY  
benzalkonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56136-011
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.56 g  in 293 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
GLYCERIN (UNII: PDC6A3C0OX)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:56136-011-01293 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E03/27/2014
Labeler - Xiamen Olivee Daily Use Chemical Co., Ltd. (526021375)
Establishment
NameAddressID/FEIBusiness Operations
Xiamen Olivee Daily Use Chemical Co., Ltd.526021375manufacture(56136-011)

Revised: 4/2014
Document Id: 46dc299e-ccb4-4ee0-bb76-da3626ca3067
Set id: dcb597d5-44f5-4947-858b-b667184fa1ab
Version: 1
Effective Time: 20140407
 
Xiamen Olivee Daily Use Chemical Co., Ltd.