Antiseptic Mouth Rinse: Package Insert and Label Information

ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate and thymol mouthwash
Strategic Sourcing Services LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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

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. Its antiseptic properties are not affected. Store at room temperature (59° — 77°F)

Inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Disclaimer

This product is not manufactered or distributed by Johnson & Johnson Healthcare Products, distributor of Original Listerine Antiseptic Mouthwash.

Adverse Reactions to Antiseptic Mouth Rinse

Another Quality Product Distributed by McKesson, One Post Street, San Francisco, CA 94104

Money Back Guarantee www.healthmart.com/healthmartbrand

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

principal display panel

Compare to Original Listerine Antiseptic Mouthwash

Health Mart

Antiseptic

Mouthrinse

antigingivitis/antiplaque

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

2X

DAY

PROTECTION

Amber

1 L (1 QT 1.8 FL OZ) 33.8 FL OZ

image description
(click image for full-size original)
ANTISEPTIC MOUTH RINSE
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0465
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL 0.92 mg in 1 mL
MENTHOL (MENTHOL) MENTHOL 0.42 mg in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.60 mg in 1 mL
THYMOL (THYMOL) THYMOL 0.64 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
BENZOIC ACID
POLOXAMER 407
SODIUM BENZOATE
CARAMEL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62011-0465-1 1000 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 06/20/2016
Labeler — Strategic Sourcing Services LLC (116956644)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (62011-0465)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (62011-0465)

Revised: 09/2022 Strategic Sourcing Services LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2022. All Rights Reserved.