FDA.reportPublic FDA data

71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine

Manufacturer
Orazen Inc | Nantong Health & Beyond Hygienic Products Inc.
Effective date
2026-09-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-09-10 00:00:54

Label at a glance#

ProductMEDI-FIRST
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure12 sections

Indications and uses

for the temporary relief of pain associated with minor burns helps protect against harmful bacteria

Dosage and administration

Adults and children 2 years and over: clean the affected area, apply a small amount not more than 3 to 4 times daily Children under 2 years: do not use, consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Lidocaine HCI 0.5%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of pain associated with minor burns
  • helps protect against harmful bacteria

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • in large quantities
  • over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns
  • for more than one week unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • the condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If ingested, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years and over:clean the affected area, apply a small amount not more than 3 to 4 times daily
  • Children under 2 years:do not use, consult a doctor

Other information

OTHER SAFETY INFORMATION

  • store at room temperature (do not freeze)
  • tamper evident sealed packets
  • do not use any opened or torn packets

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, cetearyl alcohol,disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate, mineral oil, maltodextrin, propylene glycol, purified water, palmitic acid, PEG-100 stearate,phenoxyethanol, stearic acid, sodium hydroxide

Questions or comments?

OTC - QUESTIONS SECTION

800-634-7680

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label

label 2label 2LLLL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71927-019-022025-09-03C16284748780-12cef2736-ac00-d83d-e063-dadaa90ab31f71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine
71927-019-022025-09-03C16284748780-12cef2736-ac00-d83d-e063-dadaa90ab31f71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine
71927-019-022025-01-30C16284748780-12cef2736-ac00-d83d-e063-dadaa90ab31f71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine
71927-019-022025-01-30C16284748780-12cef2736-ac00-d83d-e063-dadaa90ab31f71927-019-01, -02 MEDI-FIRST Burn cream with Lidocaine

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71927-01971927-019-01, 71927-019-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
MALTODEXTRIN7CVR7L4A2DIACT
ALOE BARBADENSIS LEAF JUICERUE8E6T4NBIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
MINERAL OILT5L8T28FGPIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PALMITIC ACID2V16EO95H1IACT
SODIUM HYDROXIDE55X04QC32IIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-09-03full-release2026-06-01 01:12:37

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf508434f-5948-7134-e053-2a95a90a03d72026-09-05WarningsExact identifier
ndc (package): 71927-019-02
ndc (package): 71927-019-01
ndc (product): 71927-019
ndc11 (package): 71927001901
ndc11 (package): 71927001902
spl id: 5abd4200-f481-aca6-e063-6294a90ac4bc
spl set id: f508434f-5948-7134-e053-2a95a90a03d7
MEDI-FIRSTBENZALKONIUM CHLORIDE, LIDOCAINEOrazen Incf522fb0b-3d86-b228-e053-2a95a90a55e92026-09-05WarningsExact identifier
ndc (package): 71927-019-01
ndc (product): 71927-019
ndc11 (package): 71927001901

Reported adverse events (FAERS/openFDA)#

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