MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Old East Main Co

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.

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Antiseptic Mouthrinse
318.003/318AH-AI

TEP

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredient

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 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 (59⁰-77⁰F)

Inactive ingredients

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

Disclaimer

100% Satisfaction Guaranteed

If you're not satisfied with this product for any reason, please call us so we can make you 100% satisfied.

(888)309-9030

Since 1903 Rexall is a registered trademark of Rexall Sundown, Inc.

Distributed by Old East Main Co.

100 Mission Ridge

Goodlettsville, TN 37072

DSP-TN-21091

DSP-MO-20087

principal display panel

DG health

Compare to Original Listerine Antiseptic Mouthwash*

ANTISEPTIC

MOUTHWASH

Antigingivitis/Antiplaque

AMBER

KILLS 99.9% OF GERMS COMMONLY ASSOCIATED WITH GINGIVITIS

Fights bad breath

Helps reduce plaque 

1.5L (50.7 FL OZ)

image description

principal display panel

Since 1903

Rexall

Amber

Antiseptic

Mouthwash

Antigingivitis/Antiplaque

ADA Accepted

Amrican Dental Association

1.5 L (1 QT 1 PT 2.7 FL OZ) 50.7 FL OZ

image description

MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-318
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARAMEL (UNII: T9D99G2B1R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/2001
2NDC:55910-318-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/2001
3NDC:55910-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/11/2001
Labeler - Old East Main Co (068331990)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55910-318)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55910-318)

Revised: 6/2023
Document Id: 07819cc2-ec53-4fbe-86c6-ce69de14dad7
Set id: 76554d61-ed96-4631-9140-135f1a2e282b
Version: 23
Effective Time: 20230606
 
Old East Main Co