ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
DZA Brands 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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Healthy Accents 664.003 664AU

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Use

help 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 of age and older - vigorously swish 20 mL between teeth for 30 seconds then spit out

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 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no.3

Disclaimer

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

Adverse Reactions

Distributed by: DZA Brands, LLC

2110 Executive Drive

Salisbury, NC 28147

For product questions or concerns contact us at 1-866-322-2439. Please include UPC number and code from package

principal display panel

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

healty

accents

blue mint

antiseptic

mouth rinse

kills germs that cause bad breath, plaque & the gum disease gingivitis

compare to the active ingredients of Listerine

1 L (33.8 FL OZ)

image description

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-664
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)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55316-664-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2008
2NDC:55316-664-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2008
3NDC:55316-664-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/05/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/05/2008
Labeler - DZA Brands LLC (090322194)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55316-664)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55316-664)

Revised: 5/2022
Document Id: 8d1104c7-d3bc-4e54-a4de-e999e69f46c7
Set id: 163f8279-30ed-4f79-a391-45df95584ed3
Version: 13
Effective Time: 20220512
 
DZA Brands LLC