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Antispetic by Harmon Stores Inc

Medically reviewed on May 11, 2018

Dosage form: mouthwash
Ingredients: EUCALYPTOL 0.92mg in 1mL, MENTHOL 0.42mg in 1mL, METHYL SALICYLATE 0.60mg in 1mL, THYMOL 0.64mg in 1mL
Labeler: Harmon Stores Inc
NDC Code: 63940-664

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

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

for this product

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

Inactive ingredients

ingredients water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium benzoate, FD&C green no. 3

ADA Statement

The ADA Council on Scientific Affairs Acceptance of Harmon Blue Mint Antiseptic Mouth rinse is based on its finding that the product is effective in helping to prevent and reduce gingivitis ad plaque above the gumline, when used as directed.

Disclaimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare Products, distributor of Cool Mint Listerine Antiseptic Mouthwash.

Adverse Reactions

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

664.002/664AR-AS

Principal Display Panel

HARMON

FACEVALUES

Compare Ours to the Active Ingredients of Listerine

BLUE MINT

MOUTHRINSE

ANTISEPTIC

Antigingivitis/Antiplaque

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

ADA

Accepted

American

Dental Association

1.5 Liter

(1 QT 1 PT 2.7 FL OZ)

Sealed With Printed Neckband For Your Protection

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63940-664
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (MENTHOL) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (THYMOL) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
SORBITOL 
POLOXAMER 407 
BENZOIC ACID 
SACCHARIN SODIUM 
SODIUM BENZOATE 
FD&C GREEN NO. 3 
Packaging
#Item CodePackage Description
1NDC:63940-664-121500 mL in 1 BOTTLE, PLASTIC
2NDC:63940-664-861000 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35605/21/1993
Labeler - Harmon Stores Inc (804085293)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIOperations
Vi-Jon790752542manufacture(63940-664)

 
Harmon Stores Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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