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

Antiseptic Mouth Rinse by

Drug Labeling and Warnings

Antiseptic Mouth Rinse by is a Otc medication manufactured, distributed, or labeled by Demoulas Super Markets, 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 you 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.  It antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)

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 statement

The ADA Council on Scientific  Affairs Acceptance of  Market Basket  Spring Mint 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.

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 Reactions

DISTRIBUTED BY:

DEMOULAS SUPER MARKETS, INC.

875 EAST STREET, TEWKSBURY, MA 01876

072.002/072AL

principal display panel

MARKET

BASKET

MORE FOR YOUR DOLLAR

COMARE TO LISTERINE

ANTISEPTIC

MOUTH RINSE

Fresh Mint

ADA

Accepted

American

Dental

Association

Kills germs that cause BAd Breath, Plaque and the gum disease Gingivitis

Sealed With Printed Neckband For Your Protection

500 mL (16.9 FL OZ)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53942-072
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)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53942-072-77	500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2007
2	NDC: 53942-072-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2007
3	NDC: 53942-072-13	1250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	03/30/2007

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/30/2007

Labeler - Demoulas Super Markets (007869647)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(53942-072)