Label: RECELLTIS WOUND CREAM- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hcl cream

  • 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 December 6, 2021

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  • Drug Facts

    Drug Facts

    Active ingredients (in each gram)

    Bacitracin Zin 400 units

    Neomycin Sulfate 5mg

    Polymyxin B Sulfate 5,000 units

    Lidocaine Hydrochloride 20mg

    Uses

    Helps prevent infection and helps promote skin repair:

    • Cuts
    • Scrapes
    • Burns
    • Bed Sores
    • Pressure Ulcers
    • Diabetic Wounds
    • Road Rash

    Warnings

    For external use only

    Do Not Use

    • In the eyes
    • Over large areas of the body

    Ask a Doctor Before Use If You Have

    • Any allergies to the ingredients

    Stop Use and Ask A Doctor If

    • condition persists or gets worse
    • rash or other allergic reaction develops

    Keep out of reach of children.

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

    Directions

    • clean the affected area
    • apply a small amount (thin layer) on the area 1 to 3 times daily
    • may be covered with a sterile bandage

    Other Information

    • store at 10° to 32C (50° to 90°F)
    • protect from freezing and avoid excessive heat

    INACTIVE INGREDIENTS

    Carboxymethyl Cellulose, Cetostearyl Alcohol, Cetyl Alcohol, Coenzyme Q-10, Purified Water, Phenoxyethanol, Polysorbate 80, Sorbitan Oleate, Tocopheryl Acetate, White Petrolatum, Zinc Gluconate

  • INGREDIENTS AND APPEARANCE
    RECELLTIS  WOUND CREAM
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71929-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE600 mg  in 30 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B150000 [USP'U]  in 30 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN12000 [USP'U]  in 30 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN105 mg  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    SILVER (UNII: 3M4G523W1G) 25 mg  in 30 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71929-070-2828 g in 1 TUBE; Type 0: Not a Combination Product10/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B06/01/2019
    Labeler - CellNovation Technology (080976562)
    Registrant - CellNovation Technology (080976562)
    Establishment
    NameAddressID/FEIBusiness Operations
    Monarch PCM, LLC080000294manufacture(71929-070)
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