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 H-e-b. 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 under 12 years of age - consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing

Inactive Ingredients



water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, sodium saccharin,flavor, sodium citrate, yellow no. 10, green no.3


Questions



Call 1-888-593-0593


Ada Council Statement



"The ADA Council on Scientific Affairs Acceptance of HEB Fresh Green Mint Antiseptic Mouthwash 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."


Disclaimer



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


Tep



SEALED WITH PRINTED NECKBAND FOR YOUR  PROTECTION


Adverse Reactions



MADE WITH PRIDE ANC ARE FOR H-E-B

SAN ANTONIO, TX 78204

072.002/072AL


Principal Display Panel



Compare to Listerine

H-E-B

Fresh Green Mint

ANTISEPTIC

ANTIGINGIVITIS/ANTIPLAQUE

MOUTHWASH

ADA

Accepted

American

Dental

Association

* Please review the disclaimer below.