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

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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Kroger 318.003/38AH-AI
Drug Facts

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 periodtitis, a serious form of gum disease.

Stop use and ask a dentist

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

Other information

cold weather may cloud this product. Its antiseptic properties are not affected. Store at room temperature (59°-77°F).

Inactive ingredients

water, alcohol 26.9%, benzoic acid, poloxamer 407, sodium benzoate, caramel

Questions or comments?

1-800-632-6900

ADA Council Statement

The ADA Council on Scientific Affairs Acceptance of Kroger Original Antisept Mouth Rinse is based opn its finding that the product is effective in helping to prevent and reduce gingivitis and plaque above the gumline, when used at directed.

Disclaimer

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

Adverse reaction

DISTRIBUTED BY THE KROGER CO.

CINCINNATI, OHIO 45202

QUALITY GUARANTEE

800-632-6900   www.kroger.com

principal display panel

COMPARE to the active ingredients of ORIGINAL LISTERINE

KROGER

FROM OUR FAMILY TO YOURS

Original

ANTISEPTIC

MOUTHRINSE

ANTIGINGIVITIS/ANTIPLAQUE

ADA

Accepted

American

Dental

Association

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

50.7FL OZ (1.5 L)

image description

ANTISEPTIC MOUTH RINSE 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-318
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARAMEL (UNII: T9D99G2B1R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-318-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/1991
2NDC:30142-318-77500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/1991
3NDC:30142-318-121500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/15/1991
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/15/1991
Labeler - Kroger Co (006999528)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(30142-318)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(30142-318)

Revised: 4/2022
Document Id: e50e1d6a-4743-4d72-9b10-b2d6a22d0d3d
Set id: 8d10d75f-e6f6-4029-8640-8cc77c61cfd2
Version: 11
Effective Time: 20220420
 
Kroger Co