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Antiseptic Mouth Rinse by Wakefern Food Corporation

Medically reviewed on April 20, 2018

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: 41190-318

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

Antiginvitis, 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 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

ADA claims

The ADA Council on Scientific Affairs Acceptance of ShopRite Original antiseptic Mouth Rinse is based on the finding that the product is effective

in helping to prevent and reduct gingivitis and plaque above the gumeline, when used as directed.

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

Adverse reaction

Distributed by:

Wakefern Food Corporation

5000 Riverside Drive

Keasbey, NJ 08832

1-800-shoprite

www.shoprite.com

318.003/AH

Compare to the Active Ingredients of LISTERINE

ShopRite

Antiseptic MOUTH RINSE

Helps to kill germs

that cause plaque, gingivitis and bad breath

ORIGINAL

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:41190-318
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 
BENZOIC ACID 
POLOXAMER 407 
CARAMEL 
Packaging
#Item CodePackage Description
1NDC:41190-318-861000 mL in 1 BOTTLE, PLASTIC
2NDC:41190-318-691250 mL in 1 BOTTLE, PLASTIC
3NDC:41190-318-121500 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/13/1990
Labeler - Wakefern Food Corporation (069722418)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(41190-318)

 
Wakefern Food Corporation

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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