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 Wakefern Food Corporation. 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



help 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 unmder 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


Ada Council Statement



The ADA council on Scientif Affairs Acceptance of ShopRite Blue Mint Antiseptic Mouth rinse is based on its finding tat the product is effective 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 Cool Mint Listerine Antiseptic Mouthwash.


Adverse Reactions



DISTRIBUTED BY:

WAKEFERN FOOD CORPORATION

5000 RIVERSIDE DRIVE

KEASBEY, NJ 08832

1-800-SHOPRITE

Satisfaction

Guaranteed

Or Your Money Back

From PriceRite


Principal Display Panel



Compare to the Active Ingredietns of LISTERINE

ShopRite

Antiseptic

MOUTH RINSE

Helps to kill germs that cause plaque,

gingivitis and bad breath

ADA

Accepted

American

Dental

Association

BLUE MINT

Sealed With Printed Neckband For Your Protection

1.5 L (50.7 FL OZ)

COMPARE TO COOL MINT LISTERINE

PRICE RITE

Antiseptic

MOUTHRINSE

Antigingivitis/Antiplaque

BLUE MINT

Helps to kill germs that

cause plaque and gingivitis

and bad breath.

SEALED WITH PRINTED NECKBAND

FOR YOUR PROTECTION

1l (33.8 FL OZ)


* Please review the disclaimer below.