Label: MYDERM BITE RELIEF- benzocaine ointment

  • 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 January 10, 2023

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient:

    Benzocaine - 5.0%

  • PURPOSE


    Benzocaine - 10.0% ............Pain Relief

  • INDICATIONS & USAGE

    Temporary relief of pain and itching associated with insect bites

  • WARNINGS

    For external use only

    When using this product • avoid contact with the eye

  • STOP USE

    Stop use and ask a doctor if • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Direction Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

    Children under 2 years of age: consult a physician

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Extract

    Camphor

    Chamomilla Recutita (Matricaria) Flower Extract

    Diazolidinyl Urea

    Disodium EDTA

    Eugenia Caryophyllus (Clove) Flower Oil

    Hydrocortisone

    Inactive Ingredients:

    Mentha Piperita (Peppermint) Oil

    Menthol

    Methylparaben

    Olea Europaea (Olive) Fruit Oil

    Papain

    PEG-2 Stearate

    PEG-2 Stearate SE

    Polyethylene

    Propylene Glycol

    Propylparaben

    SD Alcohol 40

    Water

  • PRINCIPAL DISPLAY PANEL

    MyDerm Bite Relief

  • INGREDIENTS AND APPEARANCE
    MYDERM BITE RELIEF 
    benzocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72667-019
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    PEG-2 STEARATE (UNII: 94YQ11Y95F)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    CLOVE OIL (UNII: 578389D6D0)  
    PROPYLENE GLYCOL 1,2-DISTEARATE (UNII: T65PN3O37H)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    ALOE (UNII: V5VD430YW9)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM DENSITY POLYETHYLENE (UNII: 3W404QE89S)  
    MENTHOL (UNII: L7T10EIP3A)  
    HYDROCORTISONE (UNII: WI4X0X7BPJ)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72667-019-0150 g in 1 TUBE; Type 0: Not a Combination Product12/14/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/14/2021
    Labeler - Inspec Solutions LLC. (081030372)
    Establishment
    NameAddressID/FEIBusiness Operations
    Inspec Solutions LLC.081030372manufacture(72667-019)
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!