BUENOS DIAS DE PERSONNA MINT- eucalyptol, menthol,methyl salicylate, thymol  mouthwash 
International Cosmetics Ltd.

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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Buenos Dias de Personna 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

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

Inactive ingredients

Water, Alcohol 21.6%, Sorbitol Solution, Poloxamer 407, Benzoic Acid, Sodium Benzoate ,Flavour, Sodium Saccharin & FD&C Yellow No.10 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

Personna Mint

BUENOS DIAS DE PERSONNA  MINT
eucalyptol, menthol,methyl salicylate, thymol mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66969-6002
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.092 g  in 100 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.042 g  in 100 mL
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.060 g  in 100 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.064 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
SORBITOL (UNII: 506T60A25R)  
POLOXAMER 407 (UNII: TUF2IVW3M2)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:66969-6002-21000 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/FEIBusiness Operations
International Cosmetics Ltd.857266290manufacture(66969-6002)

Revised: 3/2014
Document Id: 4499bc3c-b193-4581-bea3-3128ae4c63ca
Set id: d7876d87-070e-460c-ba3b-b51739b21eeb
Version: 1
Effective Time: 20140314
 
International Cosmetics Ltd.