Label: DERMAWOUND WOUND CARE VENOUS STASIS- benzocaine hydrochloride ointment

  • NDC Code(s): 57554-120-06
  • Packager: Progressive Doctors, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2023

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  • Active ingredient

    Benzocaine Hydrochloride (1.27%)

  • Purpose

    Local Anesthetic

  • Uses

    topical pain relief of minor

    • cuts
    • scrapes
    • burns
  • Warnings

    For external use only

  • Do not use

    • in the eyes
    • if you have methemoglobinemia
    • if pregnant or lactating
  • Ask a doctor before use

    in case of deep or puncture wounds, animal bites, or serious burns.

  • Stop use and ask a doctor if

    • the condition persists or gets worse
    • irritation or rash appears
    • you need to use the product for more than 1 week
  • Keep Out of Reach of Children

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

  • Directions

    • Gently clean around the affected area
    • Prior to application of DermaWound , evaluate the wound or ulcer to insure no excessive bleeding is present. . ®Never wipe out the ulcer
    • Apply a moderate amount of DermaWound directly to affected area. ®
    • Deeper or "tunneling" wounds may require packing and/or sides coated with additional DermaWound and sterile gauze. ®
    • Apply additional sterile gauze to absorb exudates, if needed.
    • Change Dressing 2 or 3 times daily or as directed by a physician.
    • May require supervision of a health care professional in the management of chronic & acute wound care, pressure sores, diabetic ulcers, surgical wounds & indwelling catheters.
  • Cautions

    • Persons allergic or sensitive to iodine and/or benzocaine should avoid contact with this product.
    • Do not restrict circulation when applying DermaWound with sterile gauze. ®
    • Apply additional sterile gauze to absorb exudates, if needed.
    • Change Dressing 2 or 3 times daily or as directed by a physician.
  • Other Information

    • Store at 59°-86°F (15-30°C)
    • Avoid Heat and Direct Sunlight
  • Inactive ingredients

    Sucrose (Poly-saccharide Blend), Calcium Carbonate (Poly-mineral Blend, vegan), Glycerin, Xanthan Gum, PVP-Iodine, Methylparaben, and Deionized Water.

  • Questions or Comments?

    www.DermaWound.com or 1-866-727-0462

    Non-irritating, Clinically tested, and Allergy tested.

    Certified Green Manufacturing Contents Biodegradable Eco-Friendly

    Manufactured for and Distributed by Wound Care USA, LLC Tucson, Arizona 85712

    ©2014 U.S. & International Patents Pending

    Made With Solar Power

    Made in U.S.A. NDC# 57554-120-06

    Stir if Separated

  • Package/Label Principal Display Panel

    DermaWound Professional Care ®

    Wound Care Local Anesthetic Ointment

    Venous Stasis Formula

    Net Wt. 6 oz. (179 g)

    Carton Label Carton Label

  • INGREDIENTS AND APPEARANCE
    DERMAWOUND WOUND CARE VENOUS STASIS 
    benzocaine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57554-120
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE1.27 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    WATER (UNII: 059QF0KO0R)  
    POVIDONE-IODINE (UNII: 85H0HZU99M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57554-120-061 in 1 CARTON02/02/2014
    1179 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/01/2014
    Labeler - Progressive Doctors, LLC (623841355)
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