Label: DIBUCAINE ointment

  • NDC Code(s): 71399-2829-1, 71399-2829-2
  • Packager: Akron Pharma 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 February 25, 2023

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  • Drug Facts

    Active ingredient                        Purpose

    Dibucaine 1%                  Topical Anesthetic

  • Uses

    For temporary relief of pain and itching associated with sunburn, minor burns, hemorrhoids, cuts, scratches, insect bites, stings

  • Directions

    Not for prolonged use

    Adults should not use more than 1oz in 24 hours or 1/4 oz for child

    Apply to affected area 3 or 4 times daily

    Cover with light dressing, if necessary

  • Warninigs

    For External Use Only

    Do not get into the eyes. Stop use and ask a doctor if the condition persists of if rash and irritation develops. you have rectal bleeding

  • Inactive Ingredients

    Sodium Metabisulfite, Lanolin,White Petrolatum

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    In the event of accidental ingestion, contact a Poison Control Center right away

  • STORAGE AND HANDLING

    Store at room temperature 15-30'C (59-86'F)

  • DOSAGE & ADMINISTRATION

    Apply to affected area 3 or 4 times daily

  • Questions or Comments?

    Call (877) 225-6999 Monday - Friday 9AM-5PM EST

    Manufactured for
    Akron Pharma, Inc.,
    Fairfeld, NJ - 07004

    Manufactured In USA

  • PRINCIPAL DISPLAY PANEL

    1oz

    2oz

  • INGREDIENTS AND APPEARANCE
    DIBUCAINE 
    dibucaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-2829
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIBUCAINE (UNII: L6JW2TJG99) (DIBUCAINE - UNII:L6JW2TJG99) DIBUCAINE0.28 g  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-2829-128 g in 1 TUBE; Type 0: Not a Combination Product11/04/2021
    2NDC:71399-2829-21 in 1 PACKAGE11/04/2021
    256 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34611/04/2021
    Labeler - Akron Pharma Inc. (067878881)
    Registrant - SLV PHARMACEUTICALS LLC (081225162)
    Establishment
    NameAddressID/FEIBusiness Operations
    SLV PHARMACEUTICALS LLC081225162manufacture(71399-2829)
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