Label: PROCOMYCIN- bacitracin, neomycin, polymyxin b and lidocain hydrochloride cream

  • 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 28, 2014

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  • Active ingredients

    Bacitracin 500 units

    Neomycin 3.5.mg

    Polymyxin B 10,000 units

  • Purpose

    First Aid Antibiotic

  • Active ingredient

    Lidocaine Hydrochloride 4%

  • Purpose

    Local Anesthetic

  • Uses

    • First aid to help prevent the infection in minor cuts, scrapes and burns
    • For the temporary relief of pain or itching.
  • Warnings

    For external use only.

  • Do not use

    • in the eyes
    • over large areas of the body
    • if allergic to any of the ingredients
    • longer than 1 week unless directed by a doctor.
  • Consult a doctor

    • if under 2 years of age
    • in case of deep cuts or puncture wounds, animal or human bites, or serious burns
    • if pregnant or breast feeding.
  • Stop use and consult a doctor

    • if the condition persists or worsens
    • if symptoms persist for more than 7 days or clear up and occur again within a few days
    • if a rash or other allergic reaction develops.
  • Keep out of reach of children.

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

  • Directions for use

    • Clean the affected area
    • apply a small amount of this product (an amount equal to the surface area of the tip of the finger) on the area 3 times daily.
    • may be covered with a sterile bandage
    • store at controlled room temperature 15°-30° (59°-86°).
  • Inactive ingredients

    acrylates/dimethicone coploymer, allantoin, aloe barbadensis (aloe vera) leaf juice, arachidyl alcohol, arachidyl glucoside, arnica montana flower extract, ascorbic acid (vitamin C), behenyl alcohol, beta-glucan, benzalkonium chloride, beta-glucan, butyrospermum parkii (shea) butter, C 12-15 alkyl benzoate, caprylic/capric triglyceride, cetearyl alcohol, cetearyl glucoside, cyclopentasiloxane, dimethicone, dipalmitoyl hydroxyproline, glycerin, glycine soja (soybean) oil, helianthus annuus (sunflower) seed oil, hydrolyzed mytilus edulis byssus, methylparaben, panthenol, persea gratissima (avocado) oil, phenoxyethanol, polyglyceryl-6 distearate, propylparaben, sclerotium gum, tocopherol, water (aqua)

    Manufactured in the USA for:

    Physician's Science and Nature, Inc.

    220 Newport Center Drive, 11-634,

    Newport Beach, CA 92660

    www.procomycin.com

    Repackaged By:
    Aidarex Pharmaceuticals, LLC.
    Corona, CA 92880

  • Package/Label Principal Display Panel

    IMAGE LABEL
  • INGREDIENTS AND APPEARANCE
    PROCOMYCIN 
    bacitracin, neomycin, polymyxin b and lidocain hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33261-788(NDC:27495-010)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN0.0035 g  in 1 g
    POLYMYXIN B (UNII: J2VZ07J96K) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B10000 [iU]  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33261-788-0115 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34810/01/2010
    Labeler - Aidarex Pharmaceuticals LLC (801503249)
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