KROGER COOL MINT BOOST MOUTH- eucalyptol, menthol, methyl salicylate, thymol rinse 
The Kroger Company

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 0.92%, Menthol 0.042%, Methyl Salicylate 0.060%, Thymol 0.064%

Purpose

Antigingivitis, Antiplaque

Uses

helps control plaque that leads to gingivitis, an early form of gum disease.

Warnings

Stop use and ask a dentist if

  • gingivitis, bleeding, or redness persists for more than 2 weeks.
  • you have painful or swollen gums, pus from the gum line, loose teeth, increasing space between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of reach of children under 6 years of age.

If more than used for rinsing is accidentally ingested, get medical help or contact a Poison Control Center immediately.

Directions

Adults and children 12 years of age and older: vigorously swish 20 milliliters of rinse between your teeth twice a day for 30 seconds and then spit out. Do not swallow

Children 6 years to under 12 years of age: supervise use.

Children under 6 years of age: do not use

Other information

Inactive ingredients

Water (Aqua), Alcohol (21.6%), Poloxamer 407, Flavor, Benzoic Acid, Sodium Saccharin, Sodium Benzoate, Sucralose, Green 3 (CI 42053).

Questions or comments?

1-800-632-6900

Label Copy

Image of the label

KROGER COOL MINT BOOST MOUTH 
eucalyptol, menthol, methyl salicylate, thymol rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-978
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
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-978-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/14/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35602/14/2018
Labeler - The Kroger Company (006999528)
Registrant - Apollo Health and Beauty Care Inc. (201901209)
Establishment
NameAddressID/FEIBusiness Operations
Apollo Health and Beauty Care Inc.201901209manufacture(30142-978)

Revised: 2/2018
Document Id: b5204373-20bd-46c6-8ec3-7f99d745ebbe
Set id: 24ad0af2-8694-4bf1-8cfd-0b43ba4514b5
Version: 1
Effective Time: 20180215
 
The Kroger Company