Antispetic Mouthwash
FDA Label NDC 11673-664

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Target Corporation for the product Antispetic (NDC 11673-664). 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 for this product, 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 For This Product

Warnings

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

Disclaimer

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

Ada Council Statement

The ADA Council on Scientific Affairs Acceptance of UP & UP blue mint antiseptic mouthwash is based on its finding that the product is efective in helping to prevent and reduce gingivitis and plaque above the gumline, when used as directed.

Adverse Reactions

Distributed by Target Corporation

Minneapolis, MN 55403

Made in the U.S.A. with U.S. and foreign components

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SAFETY SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ADA

Accepted

American

Dential

Association

antiseptic

mouthwash

Kills germs that cause bad breath, plaque and the gum disease gingivitis

Compare to Listerine Antiseptic Cool Mint

BLUE MINT FLAVOR

up & up

50.7 FL OZ (1.5 L)

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