FDA Label for Antispetic

View Indications, Usage & Precautions

Antispetic Product Label

The following document was submitted to the FDA by the labeler of this product Pharmacy Value Alliance Llc. 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.

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 periodontitis, a serious form of gum disease.


Stop Use And Ask A Dentist If



gingivitis, bleeding, or redness persists for more than 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 teaspoonfuls) 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 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3


Claims



*This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Cool Mint Listerine Antiseptic Mouthwash.

"The ADA council on Scientific Affairs' Acceptance of Premier Value Blue Mint Antiseptic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed."


Adverse Reactions



If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund

DISTRIBUTED BY

CHAIN DRUG CONSORTIUM

3301 NW BOCA RATON BLVD

SUITE 101, BOCA RATON, FL 33431


Principal Display Panel



SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

COMPARE TO COOL MINT LISTERINE ANTISEPTIC MOUTHWASH

Premier

Value

Antiseptic

Mouthrinse

Antigingivbitis/Antiplaque

blue mint

kills germs that cause

bad breath, plaque & the

gum disease gingivitis

ADA

Accepted

American

Dental

Association

1 L (33.8 FL OZ

INDEPENDENTLY TESTED

SATISFACTION GUARANTEED


* Please review the disclaimer below.