Label: WALGREENS PAIN RELIEF- benzocaine gel

  • 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 December 20, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Benzocaine 20%

  • Purpose

    Oral Pain Reliever

  • Uses

    • temporary relief of occasional minor irritation, pain and sore mouth
  • 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

    Stop use and ask a doctor if

    • 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.

  • Directions

    • do not use tube if it is cut prior to opening
    • cut open tip of tube on score mark
    • use your fingertip or cotton applicator to apply a small pea-size amount of Oral Pain Relief Gel
    • apply to affected area up to four times daily or as directed by a dentist or physician
    • Adults and children 2 years of age and older: Apply to affected area
    • Children under 12 years of age should be supervised in the use of this product
    • Children under 2 years of age: Consult a doctor
  • Other information

    • store at a controlled room temperature 59°-86°F (15°-30°C)
  • Inactive ingredients

    Benzyl Alcohol, Carbomer, D&C YellowNo.10, FD&C Blue No1, FD&C Red No 40, Glycerin, Methylparaben, Propylparaben, Polyethlene Glycol, Propylene Glycol, Sodium Saccharin 

  • Principal Display Panel – 0.33oz Carton Label

    Walgreens              NDC 0363-5061-33

    Oral Pain Relief

    Maxium Strength GEL

    Fast Toothache Pain Reliever

    20% Benzocaine Topical Gel 

    NET WT. 0.33 OZ (9.35g)

    Made in the USA

    Principal Display Panel – 0.33oz Carton Label

  • Principal Display Panel – 0.33oz Tube Label

     Walgreens                             NDC 0363-5061-33

    Oral Pain Relief

    Maxium Strength GEL

    Fast Toothache Pain Reliever 

    20 % Benzocaine Topical Gel 

    Made in the USA

    NET WT. 0.33 OZ (9.35g)

    Principal Display Panel – 0.33oz Tube Label

  • INGREDIENTS AND APPEARANCE
    WALGREENS PAIN RELIEF 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-5061
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-5061-331 in 1 CARTON03/19/2013
    19.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35603/19/2013
    Labeler - Walgreens Company (008965063)
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