MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Kroger

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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Herbal Mint Antiseptic Mouthwash
D01.000/D01AA rev 1

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

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

DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202

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SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

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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

image description

MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59450-901
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Eucalyptol (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) Eucalyptol.92 mg  in 1 mL
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) Menthol.42 mg  in 1 mL
Methyl salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) Methyl salicylate.60 mg  in 1 mL
Thymol (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) Thymol.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59450-901-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/21/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35603/21/2023
Labeler - Kroger (006999528)
Registrant - Vi Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC790752542manufacture(59450-901)
Establishment
NameAddressID/FEIBusiness Operations
Vi Jon, LLC088520668manufacture(59450-901)

Revised: 3/2023
Document Id: 5c560168-b089-4f4f-9243-52892b05488f
Set id: f6ccdce2-ae3c-44f7-803d-5a135a7a7e8e
Version: 1
Effective Time: 20230321
 
Kroger