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

ReCellTis by

Drug Labeling and Warnings

ReCellTis by is a Otc medication manufactured, distributed, or labeled by CellNovation Technology Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

RECELLTIS 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine hcl cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71929-069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [USP'U]  in 1 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71929-069-32	28 g in 1 TUBE; Type 0: Not a Combination Product	03/21/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	03/21/2018

Labeler - CellNovation Technology Corporation (080976562)