Label: WALGREENS BABY TEETHING- benzocaine gel, dentifrice 

  • Label RSS
  • NDC Code(s): 0363-6230-02, 0363-6230-09
  • Packager: Walgreens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 01/13

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  • Active ingredient

    Benzocaine 7.5% ...................................................................... Oral pain reliever

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  • Use

    temporarily relieves sore gums due to teething in infants and children 4 months of age and older

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  • WARNINGS

    Allergy alert: do not use this product if you have a history of allergy to local anesthetics such as
    procaine, butacaine, benzocaine or other “caine” anesthetics

    • Do not use more than directed for more than 7 days unless told to do so by a dentist or doctor.
    • When using this product fever and nasal congestion are not symptoms of teething and may indicate the presence of infection. If these symptoms do not go away, advise your dentist or doctor.
    • Stop use and ask a doctor if sore mouth symptoms do not get better in 7 days. swelling, rash or fever develops, irritation, pain or redness persists or worsens

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    • wash hands
    • cut open tip of tube on scoremark
    • use your fingertip or cotton applicator to apply a small pea-size amount of gel
    • apply to affected area up to four times daily or as directed by a dentist or doctor
    • for infants under 4 months of age, ask a dentist or doctor
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  • Other Information

    Do not use if tip is cut prior to opening.

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  • Inactive ingredients

    FD&C Red 40, Flavor, Glycerin, Polyethylene Glycols, Purified Water, Sodium Saccharin, Sorbic Acid, Sorbitol

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  • PRINCIPAL DISPLAY PANEL

    mm1.jpg

    Carton label

    mm2.jpg

    Tube Label

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  • DOSAGE & ADMINISTRATION

    • use up to 4 times daily, or as directed by a dentist or doctor • children under 12 years of age should be supervised in
    the use of this product • children under 2 years of age: consult a dentist or doctor Close
  • INGREDIENTS AND APPEARANCE
    WALGREENS  BABY TEETHING
    benzocaine gel, dentifrice
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-6230
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BENZOCAINE (BENZOCAINE) BENZOCAINE 7.5 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    POLYETHYLENE GLYCOL 400  
    POLYETHYLENE GLYCOL 3350  
    SACCHARIN SODIUM  
    SORBITOL  
    GLYCERIN  
    SORBIC ACID  
    FD&C RED NO. 40  
    WATER  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor CHERRY (Characteristic Cherry) Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-6230-09 1 in 1 CARTON
    1 NDC:0363-6230-02 14.0 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part333B 01/20/2011
    Labeler - Walgreens (008965063)
    Registrant - Lornamead (126440440)
    Establishment
    Name Address ID/FEI Business Operations
    Lornamead 126440440 manufacture(0363-6230), pack(0363-6230)
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