Label: BRACE RELIEF- benzocaine gel

  • 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 March 17, 2022

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  • ACTIVE INGREDIENTS:

    Benzocaine 9%

  • INACTIVE INGREDIENTS:

    PEG 8, PEG 75, Glycerine, Tincture of Myrrh, Menthol, Phenol, Clove Oil, Methyl Salicylate, Peppermint Oil, Methyl Paraben, Propyl Paraben.

  • DIRECTIONS:

    Apply to irritated areas as needed See package insert for instructions, warnings & cautions.

  • CAUTION:

    For temporary relief only.

    Dist.by Infa-Lab Inc., Rockaway, NJ 07866
    1996 INFA-LAB INC., Rockaway, NJ

  • PURPOSE

     

  • KEEP OUT OF REACH OF CHILDREN

     

  • INDICATIONS & USAGE

     

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel – Tube Label

    INfALAB®
    MAGIC TOUCH

    BraceRelief™
    ANESTHETIC GEL IN AN ANTISEPTIC BASE
    Relieves mouth pain
    Net Wt. 3 g.
    NDC#603061155

    Principal Display Panel – Tube Label
  • INGREDIENTS AND APPEARANCE
    BRACE RELIEF 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60306-115
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5) Benzocaine9 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Polyethylene glycol 400 (UNII: B697894SGQ)  
    Polyethylene glycol 3350 (UNII: G2M7P15E5P)  
    Glycerin (UNII: PDC6A3C0OX)  
    Myrrh (UNII: JC71GJ1F3L)  
    Menthol (UNII: L7T10EIP3A)  
    Phenol (UNII: 339NCG44TV)  
    Clove Oil (UNII: 578389D6D0)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    Peppermint Oil (UNII: AV092KU4JH)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60306-115-050.3 mL in 1 TUBE; Type 0: Not a Combination Product01/03/2005
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/03/2005
    Labeler - InfaLab,Inc (967864141)
    Registrant - PhytogenX,Inc. (010297942)
    Establishment
    NameAddressID/FEIBusiness Operations
    PhytogenX,Inc.624386772MANUFACTURE(60306-115)
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