ReCellTis

Manufacturer: CellNovation Technology Corporation
Effective date: 2018-03-21
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: legacy-cache
Hydrated at: 2026-08-02 01:00:46

Label at a glance#

ProductReCellTis

Active ingredientBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE

Label structure9 sections

Indications and uses

First aid to prevent infection, for temporary relief of pain or discomfort, and helps promote skin repair in minor: Cuts Scrapes Burns

Dosage and administration

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

Label contents#

Full prescribing information#

ReCellTis +Pain & Itch Relief First Aid Cream

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

First aid antibiotic

Local anesthetic

Uses

INDICATIONS & USAGE SECTION

First aid to prevent infection, for temporary relief of pain or discomfort, and helps promote skin repair in minor:

Cuts
Scrapes
Burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR SECTION

deep or puncture wounds
animal bites
serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

you need to use longer than 1 week
rash or other allergic reaction develops
condition persists or gets worse

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

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

SPL UNCLASSIFIED SECTION

store at 15° to 30°C (59° to 86°F)
protect from freezing and avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ReCellTis

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71929-069-32	2020-01-31	C162847	48780-1	9d75b9d0-964f-f424-e053-dadaa90a57ce	ReCellTis

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71929-069	RECELLTIS (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HCL) CREAM [CELLNOVATION TECHNOLOGY CORPORATION]	1	Legacy NDC	20180322_67f1c6b1-28a2-2b14-e053-2991aa0a656c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

ReCellTis
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine HCl
COENZYME Q10, (2Z)-
POLYSORBATE 80
PETROLATUM
CETOSTEARYL ALCOHOL
BACITRACIN ZINC
BACITRACIN
NEOMYCIN SULFATE
NEOMYCIN
POLYMYXIN B SULFATE
POLYMYXIN B
LIDOCAINE
CARBOXYMETHYLCELLULOSE
WATER
PHENOXYETHANOL
PEG-6 SORBITAN OLEATE
ALPHA-TOCOPHEROL ACETATE
ZINC GLUCONATE
CETYL ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71929-069	71929-069-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
COENZYME Q10, (2Z)-	U705VLF0VW	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PETROLATUM	4T6H12BN9U	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
BACITRACIN ZINC	89Y4M234ES	ACTIM
NEOMYCIN SULFATE	057Y626693	ACTIM
POLYMYXIN B SULFATE	19371312D4	ACTIM
LIDOCAINE	98PI200987	ACTIB
CARBOXYMETHYLCELLULOSE	05JZI7B19X	IACT
WATER	059QF0KO0R	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
PEG-6 SORBITAN OLEATE	58O7V09UCI	IACT
ALPHA-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
ZINC GLUCONATE	U6WSN5SQ1Z	IACT
CETYL ALCOHOL	936JST6JCN	IACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
67f1c6b1-28a3-2b14-e053-2991aa0a656c			67f1c6b1-28a2-2b14-e053-2991aa0a656c	2018-03-21	Warnings	Exact identifier spl id: 67f1c6b1-28a3-2b14-e053-2991aa0a656c spl set id: 67f1c6b1-28a2-2b14-e053-2991aa0a656c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.