Label: AVANT- benzocaine gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 11, 2023

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  • Active Ingredient

    Benzocaine, 20%

  • Purpose

    Oral anesthetic

  • Uses

    For the temporary relief of pain associated with canker sores and minor dental procedures.

  • Warnings

    Methemoglobinemia warning

    Use of this product may cause methemoglobinemia, a serious condition that must be treated promptly because it reduces the amount of oxygen carried in the blood. This can occur even if you have used this product before.

    Stop use and seek medical attention if you or a child in your care develops:
    • pale, gray, or blue colored skin (cyanosis)
    • headache
    • rapid heart rate
    • shortness of breath
    • dizziness or lightheadedness
    • fatigue or lack of energy

    Alergy 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 this product for more than 7 days unless directed by a dentist or doctor. If sore mouth symptoms do not improve in 7 days; if irritation, pain, or redness persists or worsens; or if swelling, rash, or fever develops, see your dentist or doctor promptly

    Do not exceed recommended dosage.

  • KEEP OUT OF REACH OF CHILDREN

    Keep Out of Reach of Children. If more than used for pain is accidentially swallowed, get medical help or contact a Poison Control center right away.

  • Directions

    • Adults and children 2 years of age and older: Apply to the affected area. 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.
  • Other Information

    Store at room temperature 59-86°F (15-30°C). Protect from freezing and heat.

  • Inactive Ingredients

    FD&C Red No. 3, FD&C Blue No. 1, Flavor, Polyethylene glycol 3350, Polyethylene glycol 400, Saccharine sodium, Tocopheryl acetate, Xylitol

  • Avant Oral Anesthetic Gel

    Gluten Free

    with 20% Benzocaine, Xylitol and Vitamin E

    1.12 oz (32 g)

    Grape

    Manufactured by Dharma Research, Inc., 5220 NW 72nd Ave, Unit 15, Miami, FL 33166

    1-877-833-3725

    www.avant-dental.com

    20201027_53045_142

  • INGREDIENTS AND APPEARANCE
    AVANT 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53045-142
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6.4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorgrapeImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53045-142-3032 g in 1 BOTTLE; Type 0: Not a Combination Product01/22/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/22/2021
    Labeler - Dharma Research, Inc. (078444642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dharma Research, Inc.078444642manufacture(53045-142)
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