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Antiseptic Mouth Rinse by Wakefern Food Corporation

Dosage form: mouthwash
Ingredients: EUCALYPTOL 0.92mg in 1mL, MENTHOL 0.42mg in 1mL, METHYL SALICYLATE 0.60mg in 1mL, THYMOL 0.64mg in 1mL
Labeler: Wakefern Food Corporation
NDC Code: 41190-072

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.

Drug Facts

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 Warnings

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, poloxamer 407, benzoic acid, flavoring, sodium saccharin, sodium citrate, citric acid, D+C yellow no. 10, FD+C green no.3

ADA Statement

The ADA  Council on Scientific Affairs Acceptance of Shop Rite Spring Mint Antiseptic Mouth Rinse is based on its finding that the product is effective in helping prevent and reduce gingivitis and plaque above the gumline, when used as directed.

Disclaimer

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

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Adverse Reactions 

Distributed By:

Wakefern Food Corp

5000 Riverside Drive

Keasbey, NJ 08832

Call: 1-800-SHOPRITE

Email: www.shoprite.com

Principal display panel

Compare to Fresh Burst Listerine*

Price Rite

Antiseptic Mouthrinse

Antigingivitis/Antiplaque

Fresh Mint

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

Sealed With Printed Neckband For Your Protection

1 L (33.8 FL OZ)

ANTISEPTIC MOUTH RINSE 
eucalyptol. menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41190-072
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (THYMOL) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
POLOXAMER 407 
BENZOIC ACID 
SACCHARIN SODIUM 
SODIUM CITRATE 
D&C YELLOW NO. 10 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage Description
1NDC:41190-072-861000 mL in 1 BOTTLE, PLASTIC
2NDC:41190-072-131250 mL in 1 BOTTLE, PLASTIC
3NDC:41190-072-121500 mL in 1 BOTTLE, PLASTIC
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 (790752542)

Revised: 02/2016
 
Wakefern Food Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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