ANTISEPTIC MOUTH RINSE- eucalyptol, menthol, methyl salicylate, thymol mouthwash
Hy-Vee, Inc.

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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Drug Facts 072 072.003/072AL Rev 2

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 information

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

ADA Seal Information

The ADA Council on Scientific Affairs Acceptance of Mint Antiseptic Mouth Rinse is based on it finding that the product is effective in helping to

revent and reduct gingivitis and plaque above the gumline, when used as directed.

This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of Listerine

DSP-TN-15000, DSP-MO-34, SDS-TN-15012

Adverse reaction

DISTRIBUTED BY HY-VEE, INC

5820 WESTOWN PARKWAY

WEST DES MOINES, IA 50266

SATISFACTIO GUARANTEED

OR PURCHSE PRICE REFUNEDED

FOR INFORMATION CALL

1-800-289-8343

www.hy-vee.com

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

principal display panel

COMPARE TO THE ACTIVE INGREDIENTS IN LISTERINE

HyVee

ORAL RINSE

ANTISEPTIC

MOUTH RINSE

Kills gersm that cause bad breath, plaque & the gu disease gingivitis

ADA

Accepted

American

Dental

Association

SPRINT MINT

1.5 LITERS (50.7 FL OZ)

image description

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42507-072
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)
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42507-072-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/23/2001	02/03/2021
2	NDC:42507-072-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	05/23/2001	02/03/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	05/23/2001	02/03/2021

Labeler - Hy-Vee, Inc. (006925671)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(42507-072)

Revised: 2/2021

Document Id: 249ebba0-b871-406e-bf04-fa236ef17ff6

Set id: 3d606078-014b-4111-9c1c-e6269dd378c1

Version: 10

Effective Time: 20210203

Hy-Vee, Inc.