Label: ORAL DENT AMBER- eucalyptol, thymol, methyl salicylate, menthol 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 13, 2014

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  • Active ingredients (W/V)

    Eucalyptol 0.092%
    Thymol 0.064%
    Methyl Salicylate 0.060%
    Menthol 0.042%

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

    Water, Alcohol 20%, Benzoic Acid, Poloxamer 407, Sodium Benzoate and Caramel.

  • SPL UNCLASSIFIED SECTION

    Manufactured by

    International Cosmetics Ltd.

    ICL Drive, Bhagowtie Trace,

    San Juan, Trinidad & Tobago, W.I.

    INFO. CALL:1-868-675-2674 

  • Packaging

    Oral dent carton

  • INGREDIENTS AND APPEARANCE
    ORAL DENT  AMBER
    eucalyptol, thymol, methyl salicylate, menthol mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66969-6020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK) EUCALYPTOL0.092 g  in 100 mL
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.064 g  in 100 mL
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.060 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.042 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:66969-6020-0500 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(66969-6020)
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