ADVANCED CITRUS- eucalyptol mouthwash

Advanced Citrus by

Drug Labeling and Warnings

Advanced Citrus by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc, 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

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 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 (59⁰-77⁰F).

INACTIVE INGREDIENT

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

ADVERSE REACTIONS

Satisfaction guaranteed-Or we'll replace it or give you  your money back.  For questions or comments or to report an undesired reaction or side effect, please call 1-888-287-1915.

Distributed by Wal-Mart Stores, Inc.,
Bentonville, AR 72716 Wal-Mart Stores,Inc

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

PRINCIPAL DISPLAY PANEL

Compare to Citrus Listerine Active Ingredients

Advanced
Antiseptic Mouthrinse
With Tartar Protection

Kills germs that cause bad breath, plaque, and the gum disease gingivitis

Fights tartar buildup better than brushing alone

Keeps teeth cleaner and brighter

Citrus

1.5 LITERS (50.7 FL OZ)

INGREDIENTS AND APPEARANCE

ADVANCED CITRUS 
eucalyptol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-210
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)
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: 49035-210-69	.25 L in 1 BOTTLE, PLASTIC
2	NDC: 49035-210-77	.5 L in 1 BOTTLE, PLASTIC
3	NDC: 49035-210-12	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	part348	07/22/2010

Labeler - Wal-Mart Stores, Inc (051957769)

Registrant - Vi-Jon (790752542)

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