Label: FAMILY WELLNESS ORAL PAIN RELIEF- benzocaine 20% gel

  • NDC Code(s): 55319-108-14
  • Packager: FAMILY DOLLAR SERVICES INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 1, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • Active ingredients

    Benzocaine 20%

  • Purpose

    Oral pain reliever

  • Uses

    temporarily relieves pain associated with the following mouth and gum irritations:

    • toothache
    • canker sores
    • minor dental procedures
    • dentures
    • sore gums
    • braces
  • 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 used 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 you have a history of allergy to local anesthetics such as procaine, butacaine, benzocaine, or other "caine" anesthetics.

    Do not use:

    • for teething
    • in children under 2 years of age

    When using this product:

    • avoid contact with the eyes
    • do not exceed recommended dosage
    • do not use for more than 7 days unless directed by a doctor/dentist

    Stop use and ask a doctor if

    • sore mouth symptoms do not improve in 7 days
    • irritation, pain, or redness lasts or worsens
    • swelling, rash, or fever develops

    Keep out of reach of children

    Keep out of reach of children.If more than used for pain is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    adults and children 2 years of age and overapply a pea-size amount to the affected area up to 4 times daily or as directed by a doctor/dentist
    children under 12 years of ageadult supervision should be given in the use of this product
    children under 2 years of agedo not use
    • For denture irritation:
    • apply thin layer to the affected area
    • do not reinsert dental work until irritation/pain is relieved
    • rinse mouth well before reinserting
  • Other information

    • store at 20-25°C (68-77°F)
    • do not refrigerate
  • Inactive ingredients

    benzyl alcohol, carbomer, D&C red no. 33, FD&C blue no. 1, FD&C yellow no. 6, glycerin, natural flavor, polyethylene glycol, polysorbate 80, propylene glycol, sodium saccharin, sorbic acid

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS  ORAL PAIN RELIEF
    benzocaine 20% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-108
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE0.2 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    SORBIC ACID (UNII: X045WJ989B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-108-141 in 1 CARTON02/01/2024
    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 DrugM02202/01/2024
    Labeler - FAMILY DOLLAR SERVICES INC (024472631)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!