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Assured by TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY

Medically reviewed on August 31, 2016

Dosage form: lotion
Ingredients: BENZALKONIUM CHLORIDE .1g in 100g
Labeler: TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY
NDC Code: 70031-002

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.

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

ASSURED 
benzalkonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70031-002
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
PROPYLENE GLYCOL 
COCAMIDOPROPYL BETAINE 
POLYAMINOPROPYL BIGUANIDE 
ALOE VERA LEAF 
.ALPHA.-TOCOPHEROL ACETATE 
PEG-54 HYDROGENATED CASTOR OIL 
EDETATE DISODIUM 
CITRIC ACID MONOHYDRATE 
METHYLCHLOROISOTHIAZOLINONE 
METHYL SOYATE 
Packaging
#Item CodePackage Description
1NDC:70031-002-0220 PACKET in 1 BAG
1NDC:70031-002-01.1 g in 1 PACKET
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)

 
TIANJIN YANSHENG INDUSTRIAL TRADE COMPANY

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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