MOUTH RINSE- eucalyptol, menthol, methylsalicylate, thymol mouthwash

Mouth Rinse by

Drug Labeling and Warnings

Mouth Rinse by is a Otc medication manufactured, distributed, or labeled by Kroger, Vi Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 informatin

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

questions or comments? 

1-800-632-6900

ADA council statement

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

Disclaimer

Listerine is a registred trademark of Johnson & Johnson Healthcare Products, New Brunswick, NJ 08903.  Johnson & Johnson Healthcare Products is not affiliated with The Kroger Co. or this product.

Adverse Reactions

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OH 45202

QUALITY GUARANTEE

800-632-6900  www.kroger.com

072.002/072AL

principal display panel

COMPARE to the active ingredients of LISTERINE * See back label

Kroger

FROM OUR FAMILY TO YOURS

Mint Burst

ANTISEPTIC

MOUTH RINSE

ANTGINGIVITIS/ANTIPLAQUE

• Kills Germs That Cause Bad Breath, Plaque & the Gum Disease Gingivitis
• For Fresher Breath

ADA

Accepted

American

Dental

Association

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

16.9 FL OZ (500 mL)

INGREDIENTS AND APPEARANCE

MOUTH RINSE 
eucalyptol, menthol, methylsalicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-072
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-072-77	500 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package	11/11/1989
2	NDC: 30142-072-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/11/1989

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	11/11/1989

Labeler - Kroger (006999528)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(30142-072)