ANTISPETIC- eucalyptol, menthol, methyl salicylate, thymol mouthwash 
C.D.M.A., 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.

----------

Drug Facts  664.003/664AT rev 2 - 664AU

Active ingredients

Eucalyptol 0.092%

Menthol 0.042%

Methyl salicylate 0.060%

Thymol 0.064%

Purpose

Antigingivitis, antiplaque

Use

helps control plaque that leads to gingivitis

Warnings

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

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

Disclaimer

This product is not manufactured or distribted by Johnson & Johnson Healthcare Products, distributor of Cool Mint Listerine

Adverse Reactions

Distributed by C.D.M.A., Inc

43157 W. Nine Mile

Novi, MI 48376-0995

www.qualitychoice.com

Questionw: 248-449-9300

principal display panel

Sealed With Printed Neckband For Your Protection

QC

Quality

Choice

Compare to

Cool Mint

LITERINE

Antiseptic

Mouth Rinse

Antigingvitis/Antiplaque

Kills Germs That Cause:

Bad Breath

Plaque

Gingiviis

Gum Disease

BLUE MINT

250 mL (8.5 FL OZ)

image description

ANTISPETIC 
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-664
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.92 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.42 mg  in 1 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.60 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-664-861000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/1995
2NDC:63868-664-69250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/11/1995
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/11/1995
Labeler - C.D.M.A., Inc (011920774)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(63868-664)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(63868-664)

Revised: 5/2022
Document Id: 37984c07-d374-4217-bfb9-d6465f2da0c6
Set id: 67ca7695-975a-4fc3-bf68-0e4151bab94b
Version: 15
Effective Time: 20220520
 
C.D.M.A., Inc