Label: PRECAINE B BUBBLEGUM- benzocaine topical anesthetic gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 22, 2020

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  • Directions

    Application Directions:

    For topical use only

    For best results apply to previously dried oral mucosa with cotton swab or similar applicator for adquate control of pain

    Removal of excess saliva during application minimizes dilution of the anesthetic and permits maximum penetration

    Not more than 1.2mg per Kg body weight per patient should be applied during a 24-hour period

  • Warnings

    Warning:

    Recommended dosage should not be exceeded due to possible side effects.

    Keep out of the reach of children.

    For professional use only.

    Do not use in the eyes.

    Avoid swallowing.

    Not for home or unsupervised consumer use.

    Not for use on children 2 and younger or pregnant or nursing women.

  • Contraindications

    Precaine B is contraindicated in patients with known hypersensitivity to benzocaine or PABA.

  • Other Information

    For product SDS information, please got to www.pascaldental.com or contact Pascal directly.

    Store product between 60 degrees F (16 degrees C) and 86 degrees F (30 degrees C)

    Rx only in USA

    Made in USA

  • Precaine B

    Precaine B

    Topical Anesthetic Gel for oral us

    Bubblegum

    Contains: Benzocaine 20% in a flavored aqueous bse

    Net Contents: 30g

    Pascal International

    2929 NE Northup Way

    Bellevue, WA 98004

    425.827.4694

    REF 15-350

    SN72506/1115

    Precaine B Bubble Gum Label

  • INGREDIENTS AND APPEARANCE
    PRECAINE B BUBBLEGUM 
    benzocaine topical anesthetic gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10866-0088
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE221 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208) 125 mg  in 1 g
    Product Characteristics
    ColorredScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10866-0088-130 g in 1 JAR; Type 0: Not a Combination Product01/27/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/27/2016
    Labeler - Pascal Company, Inc. (009260217)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pascal Company, Inc.009260217manufacture(10866-0088)
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