Antispetic Mouthwash
FDA Label NDC 11822-0664

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid Corporation for the product Antispetic (NDC 11822-0664). 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

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 Infromation

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, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, flavor, FD&C green no.3

Ada Council Statement

The ADA council on Scientific Affairs Acceptance of Rite Aid 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.

Disclaimer

This product is not manufactured or distributed by Johnson + Johnson Healthcare products, distributor of Listerine

Adverse Reactions

DISTRIBUTED BY:

Rite Aid

30 Hunter Lane, Camp Hill, PA 17011

www. riteaid.com

SATISFACTION GUARANTEE

If you are not satisfied, we'll happily refund your money

Principal Display Panel

Sealed with printed neckband for your protection

Compare to Cool Mint Listerine

Antiseptic Mouthwash

ANTISEPTIC

MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE MOUTH RINSE

BLUE MINT

help reduce plaque & gingivitis

fights bad breath

child-resistant cap

RITE

AID

PHARMACY

3.2 FL OZ (94 mL)

Image Description (Mm3)

Image Description (Mm3)

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