FDA Label for Rinse

View Indications, Usage & Precautions

Rinse Product Label

The following document was submitted to the FDA by the labeler of this product Walgreen Co. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Safety Seal



SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION


Active Ingredients



Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%


Purpose



Antigingivitis, Antiplaque


Use



helps control plaque that leads to gingivitis


Warnings



for this product


Do Not Use



if you have painful or swollen gums, pus from the gum line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontist, a serious form of gum disease.


Stop Use And Ask A Dentist



gingivitis, bleeding, or redness persists for more thatn 2 weeks


Keep Out Of Reach Of Children



If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Directions



adults and children 12 years of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonsfuls) between teeth for 30 seconds then spit out; do not swallow

children under 12 years of age - consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing

Other Information



cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).


Inactive Ingredients



water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel


Ada Council Statement



The ADA Council on Scientific Affairs Acceptance of Walgreens Original Antiseptc Mouth Rinse is based on the finding that the product is affective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed


Disclaimer



This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Listerine Antiseptic


Questions



Questions or comments? 1-888-593-0593


Adverse Reactions



DISTRIUBTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

MADE IN U.S.A. WITH U.S. AD FOREIGN COMPONENTS

318.003/318AH


Principal Display Panel



Well at

Walgreens

ANTISEPTIC - ORIGINAL

Mouth Rinse

Kills germs that cause bad breath, plaque & the gum disease gingivitis

ADA

Accepted

American

Dental

Association

Compare to Listerine Antiseptic

Active ingredients

33.8 FL OZ (1 L)


* Please review the disclaimer below.