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Benzalkonium Chloride Antiseptic

Dosage form: swab
Ingredients: BENZALKONIUM CHLORIDE 0.0013mg
Labeler: Tongzhou Ruihong Medical Products Factory
NDC Code: 58488-001

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 Ingredients

Benzalkonium Chloride  0.13%

Purpose

Antiseptic

Use

Prevent infection in minor scrapes

Warnings

For external use only
Flammable,keep away for fire or flame

Do not use:

* In large quantities
* over large areas of the body
* in eyes
* over raw or blistered areas

Stop use and ask a doctor if conditions worsen or persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.if swallowed get medical help or contact Poison control Center right away.

Directions

Adults and Children 2 year and older; Apply to cleaned affected area not more than 3 times daily.
Children under 2 years of age ; Consult a doctor

Inactive Ingredient

Purified Water

BENZALKONIUM CHLORIDE ANTISEPTIC 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58488-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.0013 mg
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage Description
1NDC:58488-001-011 SWAB in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/20/2013
Labeler - Tongzhou Ruihong Medical Products Factory (421312726)
Establishment
NameAddressID/FEIOperations
Tongzhou Ruihong Medical Products Factory421312726manufacture(58488-001)

Revised: 05/2016
 
Tongzhou Ruihong Medical Products Factory

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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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