Label: ABOVE MOUTHWASH ANTISEPTIC mouthwash

  • NDC Code(s): 73306-1160-1
  • Packager: BASTON INDUSTRIA DE AEROSSOIS LTDA
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 24, 2023

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  • ACTIVE INGREDIENT

    MENTHOL - 0,3
    METHYL SALICYLATE - 0,25

    CETYLPYRIDINIUM CHLORIDE - 0,075

  • INACTIVE INGREDIENT

    AQUA, ALCOHOL, GLYCERIN, DIPROPYLENE GLYCOL, POLYSORBATE 20, SORBITOL, SODIUM BENZOATE, AROMA, SACCHARIN, SODIUM CHLORIDE, CI 42053

  • PURPOSE

    anticavity
    antiplaque

  • INDICATIONS & USAGE

    AIDS IN THE PREVENTION OF DENTAL CAVITIES
    USING THE PRODUCT EVERY 12 HORAS, YOU GET 24 HOUR OF PROTECTION

  • QUESTIONS

    MAIL : SUPPORT@MYSPRAY.GROUP OR CALL (305) 677-5030

  • WARNINGS AND PRECAUTIONS

    KEEP OUT OF REACH OK. DO NOT USE IN CHILDREN UNDER 12 YEARS OF AGE. IF SWALLOWED SEED A DOCTOR. IF THE APPLIED AREA IS SENSITIVITY, SUSPEND USE AND SEED A DENTIST.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • DOSAGE & ADMINISTRATION

    20ML THEN SWISH FOR 30 SECONDS TWICE A DAY AFTER BRUSHING AND FLOSSING.

  • WARNINGS

    KEEP OUT OF REACH OK. DO NOT USE IN CHILDREN UNDER 12 YEARS OF AGE. IF SWALLOWED SEED A DOCTOR. IF THE APPLIED AREA IS SENSITIVITY, SUSPEND USE AND SEED A DENTIST.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ABOVE MOUTHWASH ANTISEPTIC 
    above mouthwash antiseptic mouthwash
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73306-1160
    Route of AdministrationDENTAL, BUCCAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.25 mg  in 500 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.3 mg  in 500 g
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.075 mg  in 500 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMENTHOLImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73306-1160-1500 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/24/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02107/24/2023
    Labeler - BASTON INDUSTRIA DE AEROSSOIS LTDA (897727605)
    Registrant - BASTON INDUSTRIA DE AEROSSOIS LTDA (897727605)
    Establishment
    NameAddressID/FEIBusiness Operations
    BASTON INDUSTRIA DE AEROSSOIS LTDA897727605manufacture(73306-1160)
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