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

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.

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recelltis wound 1oz tube in box

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

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

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

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

Labeler - CellNovation Technology (080976562)

Registrant - CellNovation Technology (080976562)

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