MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
United Natural Foods, Inc. dba UNFI

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

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

for is 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

TEP

Sealed With Printed Neckband For Your Protection

Disclaimer

*This product is not manufactured or distributed by Johnson & Johnson Corporation, distributor of Original Listerine Antiseptic Mouthwash.

Adverse reactions

Like it or let us make it right.

That's our quality promise.

8556-423-2630

DISTRIBUTED BY UNFI

PROVIDENCE, RI 02908 USA

DSP-TN-21091

DSP-MO-20087

Principal display panel

NDC 41163-318-86

Compare to Oringinal Listerine Antiseptic Mouthwash active ingredients*

EQUALINE

antiseptic

mouthrinse

antigingivitis/antiplaque

amber

1.L (33.8 FL OZ)

image description

MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-318
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:41163-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/2005
2NDC:41163-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/2005
3NDC:41163-318-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/2005
4NDC:41163-318-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/04/2005
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/04/2005
Labeler - United Natural Foods, Inc. dba UNFI (943556183)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(41163-318)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(41163-318)

Revised: 5/2023
Document Id: 615c32ac-18a9-43d2-9689-8e74024f5072
Set id: d9c48c72-b9df-4b3a-bc56-d887196521e2
Version: 17
Effective Time: 20230510
 
United Natural Foods, Inc. dba UNFI