RECELLTIS (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HCL) CREAM [CELLNOVATION TECHNOLOGY CORPORATION]

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  • RECELLTIS (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HCL) CREAM [CELLNOVATION TECHNOLOGY CORPORATION]

RECELLTIS (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HCL) CREAM [CELLNOVATION TECHNOLOGY CORPORATION]
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NDC 71929-069-32
Set ID 67f1c6b1-28a2-2b14-e053-2991aa0a656c
Category HUMAN OTC DRUG LABEL
Packager CellNovation Technology Corporation
Generic Name
Product Class Amide Local Anesthetic, Aminoglycoside Antibacterial, Antiarrhythmic
Product Number
Application Number PART333B
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  • ReCellTis +Pain & Itch Relief First Aid Cream

    Drug Facts

  • Active Ingredients (in each gram)

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5mg (equivalent to 3.5 mg of neomycin base)

    Polymyxin B Sulfate 5,000 units

    Lidocaine Hydrochloride 20 mg

  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

    Local anesthetic

  • Uses

    First aid to prevent infection, for temporary relief of pain or discomfort, and helps promote skin repair in minor:

    • Cuts
    • Scrapes
    • Burns
  • Warnings

    For external use only

    Do not use

    • in the eyes
    • if you are allergic to any of the ingredients
    • over large areas of the body

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • rash or other allergic reaction develops
    • condition persists or gets worse

    Keep out of reach of children.

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

  • Directions

    Adults and children 2 years of age or older:

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

    Children under 2 years of age: ask a doctor

  • Other Information

    • store at 15° to 30°C (59° to 86°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.

  • PRINCIPAL DISPLAY PANEL

    ReCellTis

  • INGREDIENTS AND APPEARANCE
    RECELLTIS 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hcl cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71929-069
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COENZYME Q10, (2Z)- (UNII: U705VLF0VW)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71929-069-3228 g in 1 TUBE; Type 0: Not a Combination Product03/21/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/21/2018
    Labeler - CellNovation Technology Corporation (080976562)
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