Label: RECELLTIS- 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 March 21, 2018

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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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