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Buenos Dias de Personna cool mint

Dosage form: mouthwash
Ingredients: EUCALYPTOL 0.092g in 100mL, MENTHOL 0.042g in 100mL, METHYL SALICYLATE 0.060g in 100mL, THYMOL 0.064g in 100mL
Labeler: International Cosmetics Ltd.
NDC Code: 66969-6003

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.

Buenos Dias de Personna cool mint


Active ingredients (W/V)

Eucalyptol 0.092%

Menthol 0.042%

Methyl Salicylate 0.060%

Thymol 0.064%

Purpose

Antiplaque/Antigingivitis

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Uses

Helps kill germs that cause plaque, gingivitis and bad breath.

Warnings
  • Do not swallow 
  • Not to be used by children under 12 years of age 

Directions

Rinse Full Strength with 2/3 ounce (20 ml) for 30 seconds twice a day to help kill germs that cause bad breath, plaque and gingivitis.

Other information

Cold temperature may cloud this product; its efficacy will not be affected. Store at room temperature (590-86F)
Do not use if security band around cap is missing or broken

Inactive ingredients

Water, Alcohol 21.6%, Sorbitol Solution, Poloxamer 407, Benzoic Acid, Sodim Benzoate ,Flavour, Sodium Saccharin and  FD&C Green  No.3.

Distributed By

2011 Energiser Personal Care LL
dba Personna International of PR
#36 Carr 20 Kim 2.2 Suite 203, Guaynabo PR00966
787-761-9500
Made in Trinidad & Tobago,W.I.

Packaging

BUENOS DIAS DE PERSONNA  COOL MINT
eucalyptol, menthol, methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66969-6003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (EUCALYPTOL) EUCALYPTOL0.092 g  in 100 mL
MENTHOL (MENTHOL) MENTHOL0.042 g  in 100 mL
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE0.060 g  in 100 mL
THYMOL (THYMOL) THYMOL0.064 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
SORBITOL 
POLOXAMER 407 
BENZOIC ACID 
SODIUM BENZOATE 
SACCHARIN SODIUM 
FD&C GREEN NO. 3 
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:66969-6003-31000 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/10/2013
Labeler - International Cosmetics Ltd. (857266290)
Establishment
NameAddressID/FEIOperations
International Cosmetics Ltd.857266290manufacture(66969-6003)

Revised: 03/2014
 
International Cosmetics Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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