ANTISEPTIC MOUTH RINSE- eucalyptol mouthwash

Antiseptic Mouth rinse by

Drug Labeling and Warnings

Antiseptic Mouth rinse by is a Otc medication manufactured, distributed, or labeled by American Sales Company, 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 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
AMERICAN SALES COMPANY
4201 WALDEN AVENUE
LANCASTER, NY14086

QUALITY GUARANTEED OR YOUR MONEY BACK

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

Compare to Citrus Advanced Listerine with Tartar Protection
Sealed with Printed Neckband for Your protection  
Care One
Antiseptic
MOUTH
RINSE
Tartar protection + Control
Citrus flavor
Helps fight tartar buildup
Fights plaque and gingivitis
Kills germs for extended plaque protection
Enhanced breath protection
1 Liter
(33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 41520-210
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: 41520-210-13	1.25 L in 1 BOTTLE, PLASTIC
2	NDC: 41520-210-86	1 L in 1 BOTTLE, PLASTIC
3	NDC: 41520-210-12	1.5 L in 1 BOTTLE, PLASTIC
4	NDC: 41520-210-69	.25 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	08/02/2010

Labeler - American Sales Company (809183973)

Registrant - Vi Jon (790752542)

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