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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Antiseptic Mouthrinse
Shop Rite 318.003/318AH-AI

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

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

ORIGINAL

Sealed With Printed Neckband For Your Protection

1 L (33.8 FL OZ)

image description

ANTISEPTIC MOUTH RINSE
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41190-318
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg in 1 mL
Methyl salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Methyl salicylate	0.60 mg in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
BENZOIC ACID (UNII: 8SKN0B0MIM)
POLOXAMER 407 (UNII: TUF2IVW3M2)
CARAMEL (UNII: T9D99G2B1R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:41190-318-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/13/1990	06/08/2023
2	NDC:41190-318-69	250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/13/1990	06/08/2023
3	NDC:41190-318-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/13/1990	06/08/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	08/13/1990	06/08/2023

Labeler - Wakefern Food Corporation (069722418)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(41190-318)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(41190-318)

Revised: 6/2023

Document Id: 069eb351-2729-4fb3-8bf2-32da28f60936

Set id: 3015d365-6a5a-4594-93fe-dd09c0a50adb

Version: 14

Effective Time: 20230608