Label: GOODSENSE ORAL PAIN RELIEF- benzocaine gel

  • NDC Code(s): 50804-191-10
  • Packager: Geiss, Destin and Dunn, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 May 25, 2022

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  • ACTIVE INGREDIENT

    Active ingredient                                                   Purpose

    Benzocaine 20%................................................. Oral pain reliever

  • PURPOSE

    Uses

    • for the temporary relief of pain due to:
    • toothache
    • canker sores
    • gum pain
    • denture pain
    • cheek bites
  • WARNINGS

    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 blood. This can occur even if you have use this product before. Stop use and seek immediate 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

    Allergy Alert: do not use this product if your child has a history of allergy to local anesthetics such as procaine, butacaine, benzocaine or other "caine" anesthetics.

  • DO NOT USE

    Do not use

    • more than directed
    • for more than 7 days unless directed by a doctor
    • for teething
    • in children under 2 years of age

  • STOP USE

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness does not go away
    • swelling, rash or fever develops
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    Adults and children 2 years of age and older

    Remove cap and cut tip of tube. Apply a small amount of product to the cavity and around gum surrounding the teeth. 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.Do not use.

  • STORAGE AND HANDLING

    Other information

    • store at 20-25°C (68°-77°F)
    • this preparation is intended for use in cases of toothaches, only as a temporary expedient until a dentist or doctor can be consulted
    • do not use continuously
  • INACTIVE INGREDIENT

    Inactive ingredients: glycerin, peppermint oil, polyethylene glycol 400, polyethylene glycol 4000, saccharin sodium, sorbitol

  • QUESTIONS

    Questions or comments?

    Call 1-888-645-8204 Monday - Friday 9AM-5PM (PST)

  • DOSAGE & ADMINISTRATION

    Distributed by:

    Perrigo Direct, Inc.

    Peachtree City, GA 30269

    www.PerrigoDirect.com

    1-888-645-8204

    Made in China

  • PRINCIPAL DISPLAY PANEL

    191

  • INGREDIENTS AND APPEARANCE
    GOODSENSE ORAL PAIN RELIEF 
    benzocaine gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50804-191
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE20 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    MINT (UNII: FV98Z8GITP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50804-191-101 in 1 CARTON12/18/2018
    114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/09/2014
    Labeler - Geiss, Destin and Dunn, Inc. (076059836)
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