The following Structured Product Label (SPL) was submitted to the FDA by Perrigo Direct, Inc for the product Antiseptic (NDC 50804-299). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
GOODSENSE
Alcohol Free Antiseptic Oral Rinse
SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION
This product is not manufactured or distributed by Procter + Gamble, distributor of Crest Pro-Health Rinse
This rinse may cause temporary staining to the surface of teeth. This is not harmful, and adequate brushing may prevent its occurrence.
Geiss, Destin and Dunn, Inc
Peachtree City, GA 30269
1-866-696-0957
Active ingredient
Cetylpyridinium chloride 0.07%
Purpose
Antigingivitis, Antiplaque
Use helps control plaque that can lead to gingivitis
Warnings
Stop use and ask a dentist if •gingivitis, bleeding or redness persists for more than 2 weeks
•you have painful or swollen gums, pus from the gun line, loose teeth or increased spacing
between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Keep out of reach of children under 6 years of age. if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.
Directions
•adults and children 6 years + older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
•do not swallow
•children 6 years to under 12 years of age: supervise use
•children under 6 years of age: do not use
Other information •this rinse is not intended to replace brushing or flossing
Inactive ingredients water, glycerin, flavor, poloxamer 188, sodium saccharin, citric acid, propylene glycol, methylparaben, propylparaben, blue 1
GOODSENSE
Alcohol Free Antiseptic Oral Rinse
Antigingivitis /Antiplaque
Mint Flavor
Compare to active ingredient of Crest Pro-Health Rinse
•Kills germs
•Helps prevent plaque
•Helps prevent gingivitis
•Helps keep teeth feeling clean
•Freshens breath
•No burn of alcohol
1 LITER (33.8 FL OZ)
* Please review the disclaimer below.
