MOUTH RINSE- eucalyptol, menthol, methyl salicylate, 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 twice a day for 30 seconds then spit out; do not swallow {the rinse}

children 6 years to under 12 years of age - supervise use

children under 6 years of age - do not use

• 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 (59°to 86°F)

Inactive ingredients

water, alcohol (21.6% v/v), sorbitol, capryl/capramidopropyl betaine, flavor, benzoic acid, Stevia rebaudiana leaf extract, sodium benzoate

Questions or Comments?

Call roll free 1-800-632-6900

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

For More Proudct Information, Scan UpcUsing Your Kroger App or Call 800-632-6900

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Breath & Gum Cleanser

ANTIGINGIVITIS/ANTIPLAQUE MOUTHWASH

WITH ESSENTIAL OILS

HERBAL MINT

fights bad breath

helps prevent plaque & gingivitis

imrproves oral hygiene

for refreshing oral care

NO ARTIFICIAL SWEETNERS OR DYES

NO POLYETHYLENE GLYCOL

33.8 FL OZ (1.05 QT) 1L

INGREDIENTS AND APPEARANCE

MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59450-901
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	0.6 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)
CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE)
BENZOIC ACID (UNII: 8SKN0B0MIM)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59450-901-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/21/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	03/21/2023

Labeler - Kroger (006999528)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(59450-901)