Handy Solutions Cool Mint LISTERINE ANTISEPTIC MOUTHWASH

Handy Solutions Cool Mint LISTERINE ANTISEPTIC MOUTHWASH

Drug Labeling and Warnings

Drug Details

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HANDY SOLUTIONS COOL MINT LISTERINE ANTISEPTIC MOUTHWASH- eucalyptol, menthol, methyl salicylate, and thymol mouthwash 
Navajo Manufacturing Company 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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Handy Solutions Cool Mint LISTERINE ANTISEPTIC MOUTHWASH

Handy Solutions Cool Mint LISTERINE ANTISEPTIC MOUTHWASH


Active ingredientsPurposes
Eucalyptol 0.092% }
Menthol 0.042% }
Methyl salicylate 0.060% }
Thymol 0.064% }
Antiplaque/antigingivitis

Uses

Helps prevent and reduce:

  • plaque
  • gingivitis

Warnings


Do not use

in children under 12 years of age

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

  • rinse full strength for 30 seconds with 20 ml (2/3 fluid ounce or 4 teaspoonfuls) morning and right
  • do not swallow

Other information

  • store at controlled room temperature 20 degree - 25 degree C (68 degree - 77 degree F)
  • cold weather may cloud this product its antiseptic properties are not affected.

Inactive ingredients

water, alcohol (21.6%),sorbitol solution, flavoring, poloxamer 407,  benzoic acid, sodium saccharin,sodium benzoate, FDandC green no. 3

Questions?


call toll-free 1-888-222-0182. weekdays

Handy Solutions Cool Mint LISTERINE ANTISEPTIC MOUTHWASH 95ml (67751-103-01)

Cool Mint Listerine Label

HANDY SOLUTIONS COOL MINT LISTERINE ANTISEPTIC MOUTHWASH 
eucalyptol, menthol, methyl salicylate, and thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67751-103
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 SALICYLATE0.6 mg  in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.64 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67751-103-0195 mL in 1 BOTTLE; Type 0: Not a Combination Product08/21/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35608/21/2013
Labeler - Navajo Manufacturing Company Inc. (091917799)
Establishment
NameAddressID/FEIBusiness Operations
Navajo Manufacturing Company Inc136941411repack(67751-103) , relabel(67751-103)
Establishment
NameAddressID/FEIBusiness Operations
Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc.801375143manufacture(67751-103)

Revised: 11/2019
 
Navajo Manufacturing Company Inc.


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