ADVANCED ANTISEPTIC- eucalyptol mouthwash

Advanced Antiseptic by

Drug Labeling and Warnings

Advanced Antiseptic by is a Otc medication manufactured, distributed, or labeled by Wakefern Food Corporation, 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 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.

DOSAGE & ADMINISTRATION

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 of flossing

STORAGE AND HANDLING

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

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

ADVERSE REACTIONS

DISTRIBUTED BY
WAKEFERN FOOD CORPORATION
5000 RIVERSIDE DR
KEASBEY, NJ 08832
1-800-SHOPRITE
www.shoprite.com

PRINCIPAL DISPLAY PANEL

Compare to Citrus Advanced Listerine
with Tartar Protection
Shop Rite
Advanced
Antiseptic
Mouth Rinse
with Tartar Protection
Helps to kill germs
that cause plaque,
gingivitis and
bad breath
CITRUS
SEALED WITH PRINTED NECKBAND FOR  YOUR PROTECTION
1.5 L (50.7 FL OZ)

INGREDIENTS AND APPEARANCE

ADVANCED ANTISEPTIC 
eucalyptol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41190-210
Route of Administration	ORAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ZINC CHLORIDE (UNII: 86Q357L16B)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 41190-210-86	1 L in 1 BOTTLE, PLASTIC
2	NDC: 41190-210-12	1.5 L in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	11/24/2010

Labeler - Wakefern Food Corporation (069722418)

Registrant - Vi-Jon (790752542)

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