Label: BUENOS DIAS DE PERSONNA ORIGINAL- eucalyptol , menthol, methyl salicylate ,thymol mouthwash

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 Label Information

Updated March 14, 2014

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  • 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

    Help 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 (590-860 F)
    Do not use if security band around cap is missing or broken.

  • Inactive ingredients

    Water, Alcohol 26.9%, Benzoic Acid, Poloxamer 407, Sodium Benzoate and Caramel.

  • 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 carton

  • INGREDIENTS AND APPEARANCE
    BUENOS DIAS DE PERSONNA  ORIGINAL
    eucalyptol , menthol, methyl salicylate ,thymol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66969-6001
    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)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARAMEL (UNII: T9D99G2B1R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCARAMELImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66969-6001-11000 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(66969-6001)
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