FDA-Drug2016-08-10Class II
Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.
Let's Talk Health, Inc.
Hazard
Marketed Without An Approved NDA/ANDA: product is an unapproved drug due to nasal decongestant claims as well as not complying with the nasal decongestant final monograph.
Sold states
Nationwide, Australia, Austria, Canada, Lebanon, Malaysia, and Philippines
Affected count
417 bottles
Manufactured in
2411 Fenton St Ste 102, Chula Vista, CA, United States
Products
Oxygen Nasal Wash (purified water, xylitol, stabilized oxygen, sodium chloride) solution, .75 oz (22mL) bottle, Distributed by: Let's Talk Health, Chula Vista, CA 91914.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1452-2016Don't want to check this manually?
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