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NDC 71929-0070-28 ReCellTis 12000; 600; 105; 150000 [USP'U]/30g; mg/30g; mg/30g; [USP'U]/30g Details

ReCellTis 12000; 600; 105; 150000 [USP'U]/30g; mg/30g; mg/30g; [USP'U]/30g

ReCellTis is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by CellNovation Technology. The primary component is BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE.

Product Information

NDC	71929-0070
Product ID	71929-070_d28337a3-e5f0-a89d-e053-2995a90a5ec5
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	ReCellTis
Proprietary Name Suffix	Wound Cream
Non-Proprietary Name	bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine HCl
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	12000; 600; 105; 150000
Active Ingredient Units	[USP'U]/30g; mg/30g; mg/30g; [USP'U]/30g
Substance Name	BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
Labeler Name	CellNovation Technology
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Antiarrhythmic [EPC], Decreased Cell Wall Synthesis & Repair [PE], Local Anesthesia [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part333B
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71929-0070-28 (71929007028)

Pricing Information	N/A
NDC Package Code	71929-070-28
Billing NDC	71929007028
Package	28 g in 1 TUBE (71929-070-28)
Marketing Start Date	2019-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8902aa55-547d-787f-e053-2a95a90a2289 Details

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

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)

Revised: 12/2021

Document Id: d28337a3-e5f0-a89d-e053-2995a90a5ec5

Set id: 8902aa55-547d-787f-e053-2a95a90a2289

Version: 3

Effective Time: 20211206