Antispetic by Liberty Chemical CO. / Vi-Jon, LLC Drug Facts  072

Antispetic by

Drug Labeling and Warnings

Antispetic by is a Otc medication manufactured, distributed, or labeled by Liberty Chemical CO., Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
Harmon Stores Inc

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.

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Drug Facts  072

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 under 12 years of age - consult a dentist or doctor

• this rinse is not intended to replace brushing or flossing

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.

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

072.002/072AL

principal display panel

HARMON

FACEVALUES

Compare Ours to the Active Ingredients of Listerine

FRESH MINT

MOUTH RINSE

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63940-072
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
SORBITOL (UNII: 506T60A25R)
POLOXAMER 407 (UNII: TUF2IVW3M2)
BENZOIC ACID (UNII: 8SKN0B0MIM)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63940-072-12	1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/1995	02/17/2020
2	NDC: 63940-072-86	1000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	10/09/1995	02/17/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part356	10/09/1995	02/17/2020

Labeler - Harmon Stores Inc (804085293)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		790752542	manufacture(63940-072)

Revised: 2/2020

Document Id: db0b26b1-131a-45c4-8875-6a70a7a37711

34390-5

Set id: 8ec5a596-45d5-49e2-9007-fe122ff72582

Version: 11

Effective Time: 20200226