Antispetic Mouthwash
FDA Label NDC 37808-664

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by H E B for the product Antispetic (NDC 37808-664). 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 active ingredients, purpose, use, warnings, do not use, stop use, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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

​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

 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 (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

Questions?

Call 1-888-593-0593

Ada Statement

The ADA Council on Scientific Affairs Acceptance of HEB Cool Blue 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 AND CARE FOR H-E-B

San Antonio, TX 78204

Principal Display Panel

Compare to Listerine

H-E-B

Cool Blue Mint

ANTISEPTIC

ANTIGINGIVITIS/ANTIPLAQUE

MOUTHWASH

ADA

ACCEPTED

American

Dental

Association

  • Helps Fight Germ That Causes Bad Breath
  • Fights Plaque & Gingivitis
  • 50.7 FL OZ (1.58 QT) 1.5 L

    Image Description (Mm3)

    Image Description (Mm3)

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