Label: DEBACHERE BUTT BALM AFTER CARE ANTISEPTIC PAIN RELIEF- benzocaine, benzalkonium chloride cream

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

Drug Label Information

Updated October 29, 2024

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

View All Sections
  • Drug Facts

  • Active Ingredients

    Benzocaine 5.00%

    Benzalkonium Chloride 0.10%

    Purpose

    Topical Analgesic

    Antiseptic

  • Uses:

    • For the temporary relief of pain associated with burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritations.
    • First aid help prevent infection in minor cuts, scrapes, and burns.
  • Warnings:

    For external use only,not intended for ingestion.

    Do not use

    • in the eyes or apply over large areas of the body. In case of deep or puncture wounds, animal bites, or serious burns, consult a doctor.

    When using this product

    • avoid contact with the eyes.

    Stop use and ask a doctor if

    • The condition persists or gets worse. Do not use longer than 1 week unless directed by a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions

    • Clean the affected area.
    • Adults and children 2 years of age and older. Apply to the affected area not more than 3 to 4 times daily.
    • Children under 2 years of age: Consult a doctor.
  • Other information:

    Store at 20-25°C (60-77°F) and protect from moisture.

  • Inactive Ingridients:

    Aloe extract, Beeswax, Camphor, Cetyl Esters, Ethyl vanillin, Helianthus (sunflower) Oil, Lanolin, Menthol, Paraffin Wax, Salicylic Acid, Theobroma Cacao (cocoa) butter, FD&C Blue # 1.

  • Package Labeling:

    Label0

  • INGREDIENTS AND APPEARANCE
    DEBACHERE BUTT BALM AFTER CARE ANTISEPTIC PAIN RELIEF 
    benzocaine, benzalkonium chloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84847-540
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE50 mg  in 1 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE (UNII: V5VD430YW9)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    LANOLIN (UNII: 7EV65EAW6H)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    COCOA (UNII: D9108TZ9KG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84847-540-003 mL in 1 PACKET; Type 0: Not a Combination Product09/27/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/27/2024
    Labeler - DE.BACHERE USA LLC (127815393)
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!