Label: EQUATE ORASOL- 20% benzocaine gel

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated May 29, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active ingredient

    Benzocaine 20%

  • Purpose 

    Oral Pain Reliever

  • Uses

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

    Methemoglobinema Warning: Use of this product may cause Methemoglobinema, a serious condition that must be treated promptly becasue it reduces the amount of oxygem carried in the blood. This can occur even if you have used this product before. Stop use and seek immeditate medical attention if you or a child in yuor care develops;

    • pale, gray, or blue colored skin(cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    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

    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
  • Inactive ingredients

    Benzyl Alcohol, Carbomer, D&C Yellow No 10, FD&C Blue No 1, FD&C Red No 40, Flavor, Glycerin, Methylparaben, Polyethylene Glycol, Propylene Glycol, Sodium Saccharin

  • Other information 

    store at a controlled room temperature 68°- 77°F (20°-25°C)

  • Principal Display Panel 

    NDC 79903-966-09

    Oral Pain Relief

    MAXIMUM STRENGTH GEL

    Benzocaine 20% NET WT. 0.33 OZ (9.35g)

    Walmart_Orasol_0.33oz Carton

    Walmart_Orasol_0.33oz Tube

  • INGREDIENTS AND APPEARANCE
    EQUATE ORASOL 
    20% benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79903-966
    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 3350 (UNII: G2M7P15E5P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79903-966-091 in 1 CARTON04/30/2024
    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 DrugM02204/30/2024
    Labeler - WAL-MART STORES INC. (051957769)