RECELLTIS- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hcl cream 
CellNovation Technology Corporation

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.

----------

ReCellTis

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:

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:

Children under 2 years of age: ask a doctor

Other Information

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

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)

Revised: 3/2018
Document Id: 67f1c6b1-28a3-2b14-e053-2991aa0a656c
Set id: 67f1c6b1-28a2-2b14-e053-2991aa0a656c
Version: 1
Effective Time: 20180321
 
CellNovation Technology Corporation