ADVANCED ANTISEPTIC- eucalyptol mouthwash

Advanced Antiseptic by

Drug Labeling and Warnings

Advanced Antiseptic by is a Otc medication manufactured, distributed, or labeled by Demoulas Super Markets, Inc, Vi Jon , Vi Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients
Eucalyptol 0.092%    Menthol 0.042%    Methyl salicylate 0.060%  Thymol 0.064%

Purpose
Antigingivitis, Antiplaque

INDICATIONS & USAGE

Use helps control plaque that leads to gingivitis

WARNINGS

Warnings

Do not use if you have painful or swollen guns, pus from the gum line, loose teeth or increased spacing between the teeth.  See your dentist immediately.  This may be signs of periodontitis a serious form of gum disease.

Stop use and as 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.

DOSAGE & ADMINISTRATION

Directions
adults and children 12 year of age and older - vigorously swish 20 mL (2/3 FL OZ or 4 teaspoonfuls) between teeth for 30 seconds then pit out; do not                                                                    swallow
children under 12 year of age - consult a dentist or doctor
this rinse is not intended to replace brushing or flossing

STORAGE AND HANDLING

Other information cold weather may cloud this product.  Its antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)

INACTIVE INGREDIENT

Inactive ingredients water, alcohol (21.6%), sorbitol solution, flavoring, PEG-40 hydrogenated castor oil, poloxamer 407, benzoic acid, zinc chloride, sucralose and/or sodium saccharin, sodium benzoate, yellow 6, red 40

SPL UNCLASSIFIED SECTION

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

ADVERSE REACTIONS

DISTRIBUTED BY
DEMOULAS SUPER MARKETS, INC
875 EAST STREET
TEWKSBURY, MASS.  01879
MADE IN THE USA

SPL UNCLASSIFIED SECTION

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

PRINCIPAL DISPLAY PANEL

Sealed With Printed Neckband For Your Protection
Market Basket
Compare to Citrus Advanced Listerine with Tartar Protection
ADVANCED
ANTISEPTIC
MOUTH RINSE
Citrus
with Tartar Protection
Kills germs that cause bad breath, plaque + the gum disease gingivitis
Fights tartar buildup better than bushing alone
Keeps teeth cleaner + brighter
1L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ADVANCED ANTISEPTIC 
eucalyptol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53942-210
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	.092 kg  in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	.042 kg  in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	.060 kg  in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	.064 kg  in 100 L

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ZINC CHLORIDE (UNII: 86Q357L16B)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53942-210-86	1 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	07/22/2010

Labeler - Demoulas Super Markets, Inc (007869647)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture