Antiseptic Mouthrinse Mouthwash
FDA Label NDC 69892-072

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rockland Cosmetics, Inc. for the product Antiseptic Mouthrinse (NDC 69892-072). 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 if, 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 sailcylate 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 incresed 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 rednss 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 under 12 years if 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 propeties 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, yellow 10, green 3

Questions Or Comments?

Call 877-757-5005

Adverse Reaction

Distributed By: Rockland Cosmetics, Inc.

Hillburn, NY

www.RocklandCosmetics.com

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

NSK

New Square Kashrus

DSP-TN-21091

DSP-MO-20087

Principal Display Panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

mint'evo

REVOLUTIONIZINGG ORAL FRESSNESS

ANTISEPTIC MOUTHWASH

ANTIGINGIVITIS/ANTIPLAQUE

KILLS GERMS THAT CAUSE BAD BREATH, PLAQUE AND GINGIVITIS THE GUM DISEASE

SPRING MINT

500 Ml (1.05 pt) 16.9 FL OZ

Image Description (Mm01)

Image Description (Mm01)

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