ASSURED- benzalkonium chloride lotion 
TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY

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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Active ingredient

Benzalkonium chloride 0.115%

Purpose

Antibacterial

Use   decreases bacteria on skin

Warnings

For external use only

Do not use

-over large areas of the body if you are allergic to any of the ingredients

When using this product avoid contact with eyes and face.

If contact occurs, flush thoroughly with water.

Stop use and ask a doctor if irritation or rash develops and

continues for more than 72 hours

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away

Directions

-for adults and children of 2 years and over use

on hands and face to clean and refresh, allow skin to air dry.

-For children under 2 years ask a doctor before using

Inactive ingredient

Water, propylene glycol, glycerin, cocamidopropyl

betaine, polyaminopropyl biguanide, aloe barbadensis leaf extract,

tocopheryl acetate, peg-54 hydrigenated castor oil, disodium edta,

citric acid, fragrance, methylchloroisothiazolinone,

methylsothiazolinone

image description

ASSURED 
benzalkonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70031-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEG-54 HYDROGENATED CASTOR OIL (UNII: 0WZF1506N9)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYL SOYATE (UNII: 808DL597QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70031-002-0220 in 1 BAG08/31/2016
1NDC:70031-002-01.1 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A08/31/2016
Labeler - TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY (679914791)

Revised: 8/2016
Document Id: 827a39c0-4324-4725-8787-b29cee24a575
Set id: bcd59ea1-b11e-4e40-b7e9-372f90bf3dc4
Version: 1
Effective Time: 20160831
 
TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY