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Antispetic

Harmon Stores Inc
Vi-Jon

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Use

help 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

 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.

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 unmder 12 years of age - consult a dentist or doctor

  • this rinse is not intended to replace brushing or flossing

Antispetic Other information

Cold weather may cloud this product.  Its antiseptic properties are not affected.  Store atroom temperature (59º and 77º F)

Inactive ingredients

water, alcohol 21.6%, sorbitol, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium citrate, D+C yellow no. 10,  FD+C green no.3

ADA Statement

The ADA Council on Scientific Affairs Acceptance of Harmon Fresh 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.

Disclaimer

This product is not manufactured or distributed by Johnson + Johnson Healthcare Products, distributor of FreshBurst Listerine Antiseptic Mouthwash.

Side Effects

Distributed by Harmon Stores, Inc.

650 Liberty Ave., Union, NJ 07083 USA

Harmon Stores, Inc.

Visit us at: www.facevlaues.com

Made in the USA with US and foreign components

DSP-TN-15000  DSP-MO-34  SDA-TN-15012

Principal Display Pane

Compare Ours to the Active Ingredients of Listerine

FRESH MINT

MOUTHRINSE

ANTISEPTIC

Antigingivitis/Antiplaque

Kills germs that cause Bad Breath, Plaque + the gum disease Gingivitis

ADA

Accepted

Dental

Association

1.5 Liter

(1 QT 1PT 2.7 FL OZ)

Sealed With Printed Neckband For Your Protection

Antispetic

Antispetic

Eucalyptol, menthol, methyl salicylate, thymol MOUTHWASH

Product Information

Product Type Human otc drug label Item Code (Source) NDC:63940-072
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
EUCALYPTOL EUCALYPTOL 0.92 mg
MENTHOL 0.42 mg
methyl salicylate METHYL SALICYLATE 0.60 mg
THYMOL THYMOL 0.64 mg

Inactive Ingredients

Ingredient Name Strength
water
ALCOHOL
sorbitol
POLOXAMER 407
BENZOIC ACID
saccharin sodium
SODIUM CITRATE
D&C YELLOW NO. 10
FD&C GREEN NO. 3

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63940-072-12 1500 in 1 BOTTLE, PLASTIC
2 NDC:63940-072-86 1000 in 1 BOTTLE, PLASTIC

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part356 1995-10-09


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