FDA.reportPublic FDA data

ReCellTis

Manufacturer
CellNovation Technology | Monarch PCM, LLC
Effective date
2021-12-06
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:45:26

Label at a glance#

ProductReCellTis Wound Cream
Active ingredientLIDOCAINE, POLYMYXIN B SULFATE, BACITRACIN ZINC, NEOMYCIN SULFATE
Label structure1 sections

Label contents#

Full prescribing information#

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug FactsDrug Facts

Active ingredients (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Bacitracin Zin 400 units

Neomycin Sulfate 5mg

Polymyxin B Sulfate 5,000 units

Lidocaine Hydrochloride 20mg

INDICATIONS & USAGE SECTION

Uses

OTC - PURPOSE SECTION

Helps prevent infection and helps promote skin repair:

  • Cuts
  • Scrapes
  • Burns
  • Bed Sores
  • Pressure Ulcers
  • Diabetic Wounds
  • Road Rash

Warnings

WARNINGS SECTION

For external use only

Do Not Use

OTC - DO NOT USE SECTION

  • In the eyes
  • Over large areas of the body

Ask a Doctor Before Use If You Have

OTC - ASK DOCTOR SECTION

  • Any allergies to the ingredients

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Stop Use and Ask A Doctor If

OTC - STOP USE SECTION

  • 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

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

  • store at 10° to 32C (50° to 90°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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2001994bacitracin zinc 400 UNT / lidocaine HCl 20 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical CreamPSN3
2001994bacitracin zinc 0.4 UNT/ML / lidocaine hydrochloride 0.02 MG/ML / neomycin 0.0035 MG/ML / polymyxin B 5 UNT/ML Topical CreamSCD3
2001994bacitracin zinc 400 UNT / lidocaine HCl 20 MG / neomycin 3.5 MG / polymyxin B 5,000 UNT per GM Topical CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BACITRACIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
NEOMYCIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
POLYMYXIN B Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
99e684e6-f435-feb8-d2bb-3a546f1cb768Product name220161117
25340b3b-3e4c-4ff8-abf6-3e62ec46bd0cProduct name120160603
2d352c73-a357-4193-a4de-dfdf9a2ac8e4Product name120150819
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
b6082387-f592-1148-0844-bd068fd213fbProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71929-070-282024-01-30C16284748780-11030e365-3fdf-111a-e063-dadaa90a10e2recelltis wound 1oz tube in box

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71929-070-28ReCellTisWound Cream28 g in 1 TUBECREAM283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71929-070RECELLTIS WOUND CREAM (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HCL) CREAM [CELLNOVATION TECHNOLOGY]3Legacy NDC, 1 package rows20211207_8902aa55-547d-787f-e053-2a95a90a2289.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71929-07071929-070-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILVER3M4G523W1GIACT
LIDOCAINE98PI200987ACTIB
POLYMYXIN B SULFATE19371312D4ACTIM
BACITRACIN ZINC89Y4M234ESACTIM
NEOMYCIN SULFATE057Y626693ACTIM

Source Document#

Source XML

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d28337a3-e5f0-a89d-e053-2995a90a5ec58902aa55-547d-787f-e053-2a95a90a22892021-12-06WarningsExact identifier
spl id: d28337a3-e5f0-a89d-e053-2995a90a5ec5
spl set id: 8902aa55-547d-787f-e053-2a95a90a2289

Reported adverse events (FAERS/openFDA)#

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