FDA-Device2013-11-20Class II

Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth

GlaxoSmithKline, LLC.
Hazard

Label indicates, "Sweetened with xylitol and Sorbitol", however product does not contain sorbitol.

Sold states
Nationwide Distribution .
Affected count
483,204 bottles
Manufactured in
1011 North Arendell Ave, Zebulon, NC, United States
Products
Biotene Moisturizing Mouth Spray, with xylitol, For dry mouth symptom relief, 44.3ml/1.5 FL. OZ., Sugar Free Sweetened with xylitol and sorbitol, GlaxoSmithKline, Consumer Healthcare, L.P., Moon Township, PA 15108. Biotene Mouth Spray is used for the treatment of dry mouth

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0272-2014

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