ANTISEPTIC MOUTH RINSE- eucalyptol. menthol, methyl salicylate, thymol mouthwash 
Wakefern Food Corporation

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
072.003/072AN

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 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


•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 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D&C yellow no.10,  FD&C green no.3

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

Distributed By:

Wakefern Food Corp

5000 Riverside Drive

Keasbey, NJ 08832

Satisfaction guaranteed or your money back

principal display panel

Compare to the Active Ingredients of Listerine*

ShopRite

Antiseptic

Mouth Rinse

Helps to kill germs that cause plaque,gingivitis and bad breath

FRESH MINT

ADA Accepted

American Dental Association

Sealed With Printed Neckband For Your Protection

1.5 L (50.7 FL OZ)

image description

principal display panel

COMPARE TO FRESH BURST LISTERINE*

PRICE RITE

Antiseptic MOUTHRINSE

Antigingivitis/Antiplaque

FRESH MINT

Helps kill germs that cause plaque and gingivitis and bad breath

SEALED WITH PREINTED NECKBAND FOR YOUR PROTECTION

1L (33.8 FL OZ)

image description

ANTISEPTIC MOUTH RINSE 
eucalyptol. menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-072
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:41190-072-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/1999
2NDC:41190-072-131250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/1999
3NDC:41190-072-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/28/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/28/1999
Labeler - Wakefern Food Corporation (069722418)
Registrant - Vi-Jon, LLC (790752542)

Revised: 1/2023
Document Id: 1a39942d-7d78-475e-8214-f443a9f45dd0
Set id: 7a9f7eeb-78ae-4e7e-9a65-ee127786e245
Version: 11
Effective Time: 20230131
 
Wakefern Food Corporation