ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%
Available from:
Marc Glassman, Inc
Administration route:
ORAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antigingivitis, antiplaque help control plaque that leads to gingivitis 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. gingivitis, bleeding, or redness persists for more than 2 weeks.
Authorization status:
OTC monograph not final
Authorization number:
68998-664-12

ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash

Marc Glassman, 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

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpos e

Antigingivitis, antiplaque

Us e

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 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.

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 at room

temperature (59°-77°F)

Inactive ingredients

water, alcohol 21.6%, sorbitol solution, flavor, poloxamer 407, benzoic acid, sodium saccharin, sodium

benzoate, FD&C green no.3

Dis claimer

This product is not manufactured or distributed by Johnson & Johnson Healthcare products, distributor

of Cool Mint Listerine Antiseptic Mouthwash.

Adverse Reactions

Distributed by:

Marc Glassman, Inc

West 130th Street

Cleveland, OH 44130

DSP-TN-15000

DSP-MO-34

SDS-TN-15012

66.002/664AT

principal display panel

NDC 68998-664-12

Compare to Cool Mint Listerine Mouthwash

Marc's

Fresh Savings, Smart Living

Antiseptic

Mouthwash

HELPS IMPROVE ORAL HYGIENE

Kills Germs that Cause

Plaque

Gingivitis

Bad Breath

Blue Mint Flavor

1.L (50.7 FL OZ)

ANTISPETIC

eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 8 9 9 8 -6 6 4

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

EUCALYPTO L (UNII: RV6 J6 6 0 4TK) (EUCALYPTOL - UNII:RV6 J6 6 0 4TK)

EUCALYPTOL

0 .9 2 mg in 1 mL

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A)

MENTHOL

0 .42 mg in 1 mL

METHYL SALICYLATE (UNII: LAV5U50 22Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)

METHYL SALICYLATE

0 .6 0 mg in 1 mL

THYMO L (UNII: 3J50 XA376 E) (THYMOL - UNII:3J50 XA376 E)

THYMOL

0 .6 4 mg in 1 mL

Marc Glassman, Inc

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

SO RBITO L (UNII: 50 6 T6 0 A25R)

PO LO XAMER 4 0 7 (UNII: TUF2IVW3M2)

BENZO IC ACID (UNII: 8 SKN0 B0 MIM)

SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

FD&C GREEN NO . 3 (UNII: 3P3ONR6 O1S)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 8 9 9 8 -6 6 4-

150 0 mL in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/22/20 19

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt356

0 4/22/20 19

Labeler -

Marc Glassman, Inc (094487477)

Registrant -

Vi-Jon (790752542)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n

79 0 752542

ma nufa c ture (6 8 9 9 8 -6 6 4)

Revised: 4/2019

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