Antiseptic Mouthwash
FDA Label NDC 67091-102

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winco Foods, Llc for the product Antiseptic (NDC 67091-102). 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 and ask a dentist if, 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 0.030%

Thymol 0.064%

Purpose

antigingivituis, 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 Information

cold weather may cloud this product.  It 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 citrate, D&C yellow no. 10, FD&C green no.3

Questions?

Or to report an adverse even call 800-824-1706

Monday - Friday 9am -4pm MST

Ada Council Statement

"The ADA Council on Scientific Affairs" Acceptance of WinCo Foods Spring Mint Antisetpic Mouth Rinse is based on its finding that the product is effective in helping to prevent and reduct 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 Freshburst LISTERINE Antiseptic Mouthwash.

Adverse Reactions

DISTRIBUTED BY:WINCO FOODS, LLC BOISE, ID 83704

Comments & Questions?

800-824-1706  www.wincofoods.com

Principal Display Panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Compare to the active ingredients in

Freshburst LISTERINE Antiseptic Mouthwash

WinCo

FOODS

ANTISEPTIC

MOUTH RINSE

ANTIGINGIVITIS/ANTIPLAQUE

MOUTH RINSE

Kills Germs That Cause Bad Breath,

Plaque and Gingivitis Gum Disease

For Better Oral Hygiene and

Fresher Breath

ADA

Accepted

American

Dental

Association

Spring Mint

33.8 FL OZ (1 QT 1.8 FL OZ)

Image Description (Mm2)

Image Description (Mm2)

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