RECELLTIS WOUND CREAM- 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, Monarch PCM, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71929-070
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	600 mg  in 30 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	150000 [USP'U]  in 30 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	12000 [USP'U]  in 30 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	105 mg  in 30 g

Inactive Ingredients
Ingredient Name	Strength
SILVER (UNII: 3M4G523W1G)	25 mg  in 30 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71929-070-28	28 g in 1 TUBE; Type 0: Not a Combination Product	10/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	06/01/2019

Labeler - CellNovation Technology (080976562)

Registrant - CellNovation Technology (080976562)

Establishment
Name	Address	ID/FEI	Business Operations
Monarch PCM, LLC		080000294	manufacture(71929-070)