ANTISEPTIC- eucayptol, menthol, methyl salicylate, thymol mouthwash 
Perrigo Direct, Inc.

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 saliclate 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 gun line, loose teeth or increased spacing between the teeth. See your dentist immediately. These may be signs of periodontitis, a serous 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 teaspoonsfuls) between teeth for 30 seconds then spit out; do not swallow

children under 12 years of age - consult a dentist or doctor

Other information

cold weather may cloud this product. Its antiseptic properites are not affected. Store at room temperature (59°-77°F).

Inactive ingredients

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

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

Distributed by

Perrigo Direct, Inc.

Peachtree City, GA 30269

1-888-593-0593

GoodSense is a registered trademark of L. Perrigo Company.

DSP-TN21091

DSP-MO-20087

Principal display panel

Sealed With Printed Neckband For Your Protection

GoodSense

NDC 5084-318-12

Antiseptic Mouth Rinse

Original

Kills Germs That Cause

Bad Breath, Plaque & The Gum Disease Gingivitis

ADA Accepted American Dental Association

• Helps prevent and reduce plaque
• Helps prevent and reduce gingivitis

Compare to active ingredients of Listerine

1.5 Liters (50.7 FLOZ)

image description

ANTISEPTIC 
eucayptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-318
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:50804-318-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1990
2NDC:50804-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1990
3NDC:50804-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1990
4NDC:50804-318-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product09/15/1990
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/15/1990
Labeler - Perrigo Direct, Inc. (076059836)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(50804-318)

Revised: 6/2023
Document Id: 4f5024af-308a-4f12-a604-0ef2ebf98664
Set id: 50776776-80aa-4098-8cf3-6daa0b305b15
Version: 15
Effective Time: 20230607
 
Perrigo Direct, Inc.