ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Retail Business 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.

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Antiseptic Mouthrinse
318.003/318AH-AI

TEP

Sealed With Printed Neckband For Your Protection

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 gingvitis

Warnings

for this product

Do not use

if you have painful or swollen gums, pus from the fum 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 teaspoonfruls) between teeth for 30 seconds than 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 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 manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Original Listerine Antiseptic Mouthwash.

Adverse Reaction

DISTRIBUTED BY FOODHOLD, U.S.A., LLC

LANDOVER, MD 20785   

1-877-846-9949

(c) 2018 S&S Brands, LLC

Quality guaranteed or your money back.

principal display panel

CAREONE

Compare to Original Listerine Antiseptic Mouthwash*

ANTISEPTIC

MOUTH RINSE

ANTIGINGIVITIS/ANTIPLAQUE

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

ORIGINAL FLAVOR

33.8 FL OZ (1.05 QT) 1L

image description

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-318
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:72476-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/1989
2NDC:72476-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/1989
3NDC:72476-318-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/13/1989
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/13/1989
Labeler - Retail Business Services, LLC (967989935)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(72476-318)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(72476-318)

Revised: 6/2023
Document Id: 12d53d19-cb3b-43c3-9315-3e1fda1bdc1a
Set id: 472afa70-fdb4-43ac-a3b9-4841fb2f43bc
Version: 13
Effective Time: 20230606
 
Retail Business Services, LLC