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 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 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.

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.  It antiseptic properties are not affected.  Store at room temperature (59⁰ - 77⁰ F)

INACTIVE INGREDIENT

Inactive ingredients water, alcohol 21.6%, sorbitol solution, poloxamer 407, benzoic acid, flavoring, sodium saccharin, sodium citrate, citric acid, D+C yellow, FD+C green no. 3

SPL UNCLASSIFIED SECTION

The ADA Council on Scientific  Affairs Acceptance of Good Sense 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

DISTRIBUTED BY:
Vi-Jon
8515 Page Avenue
St. Louis, MO 63114
1-888-593-0593

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

PRINCIPAL DISPLAY PANEL

Sealed With Printed
Neckband For your Protection

Compare to the Active Ingredients in Listerine

Good Sense 
NDC: 11344-072-86

ANTISEPTIC
MOUTH RINSE

Kills Germs that Cause
Bad Breath, Plaque +
The Gum Disease Gingivitis

ADA
Accepted
American
Dental
Association

1L (33.8 FL OZ)

INGREDIENTS AND APPEARANCE

ANTISEPTIC MOUTH RINSE 
eucalyptol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-072
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.092 kg  in 100 L
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.042 kg  in 100 L
METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y)	METHYL SALICYLATE	0.060 kg  in 100 L
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.064 kg  in 100 L

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-072-86	1 L in 1 BOTTLE, PLASTIC
2	NDC: 11344-072-69	.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	08/15/2009

Labeler - Vi Jon (150931459)

Registrant - Vi Jon (150931459)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		150931459	manufacture