ANITSEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Pharmacy Value Alliance 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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Spring Mint Antiseptic Mouthrinse
072.003/072AL rev2-AN

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose section

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 of age 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

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 citrate, D&C yellow no.10, FD&C green no.3

Questions?

1-888-593-0593

*This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Freshburst Listerine Antiseptic Mouthwash.

If for any reason you are not satisified with this product, please return it to the store where purchased for a full refund.

Distributed by:

Pharmacy Value Alliance LLC

407 East Lancaster Avenue,

Wayne, PA 19087

principal display panel

SEALED WITH PRINTED NECKBAND FOR Y0UR PROTECTION

COmPARE TO FRESHBURST LISTERINE ANTISEPTIC MOUTHWASH*

Premier Value

Antiseptic Mouthrinse

Antigingivitis/Antiplaque

spring mint

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

1 L (33.8 FL OZ)

image description

ANITSEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-941
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 SOLUTION (UNII: 8KW3E207O2)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-941-771000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product08/19/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34808/19/2003
Labeler - Pharmacy Value Alliance LLC (101668460)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(68016-941)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(68016-941)

Revised: 1/2023
Document Id: b6c3e199-311c-4163-8b4b-3dd27b77f190
Set id: 6d611caa-b382-48f9-b954-8ea5cf198aa2
Version: 17
Effective Time: 20230131
 
Pharmacy Value Alliance LLC