FDA.reportPublic FDA data

78495-142 MEDI-FIRST Topical Analgesic

Manufacturer
Ultra Distributors Inc | Nantong Health & Beyond Hygienic Products Inc.
Effective date
2026-09-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-09-10 00:01:01

Label at a glance#

ProductMEDI-FIRST Topical Analgesic
Active ingredientLIDOCAINE HYDROCHLORIDE
Label structure12 sections

Indications and uses

Temporary pain relief associated with minor burns

Dosage and administration

spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily not to be used on Children under 12 years of age

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 2.0%

Purpose

OTC - PURPOSE SECTION

Topical pain relief

Uses

INDICATIONS & USAGE SECTION

Temporary pain relief associated with minor burns

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • in large quantities, particularly over raw or blistered areas
  • near eyes, if this happens rinse thoroughly with water

Stop use and ask a doctor

OTC - STOP USE SECTION

if condition worsens or persists for more than 7 days or clears up and returns.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • spray an even layer of burn spray over cleaned affected area not more than 3-4 times daily
  • not to be used on Children under 12 years of age

Inactive ingredients

INACTIVE INGREDIENT SECTION

aminomethyl propanol, glycerin, hydroxypropyl methylcellulose, melaleuca alterniflia (tea tree) leaf oil, octoxynol 9,PEG-40 hydrogenated castor oil, phenoxyethanol, propylene glycol, water

Questions or comments?

OTC - QUESTIONS SECTION

1-800-634-7680

SPL UNCLASSIFIED SECTION

Topical Analgesic

Relieves pain in minor burns

Store at 68°-77°F (20°-25°C)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130347682225025GTIN-13: 0347682225025
EAN-13: 0347682225025
GTIN-12: 347682225025
UPC-A: 347682225025
GTIN storage (14 digits): 00347682225025		78495 142 JPG.jpg

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
78495-142-012025-04-07C16284748780-12cef2736-7044-d83d-e063-dadaa90ab31f78495-142
78495-142-012025-04-07C16284748780-12cef2736-7044-d83d-e063-dadaa90ab31f78495-142 MEDI-FIRST Topical Analgesic
78495-142-012025-01-30C16284748780-12cef2736-7044-d83d-e063-dadaa90ab31f78495-142
78495-142-012025-01-30C16284748780-12cef2736-7044-d83d-e063-dadaa90ab31f78495-142 MEDI-FIRST Topical Analgesic

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
78495-14278495-142-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
OCTOXYNOL-97JPC6Y25QSIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
AMINOMETHYL PROPANOLLU49E6626QIACT
HYPROMELLOSES3NXW29V3WOIACT
TEA TREE OILVIF565UC2GIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-04-07full-release2026-06-01 00:58:47

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
MEDI-FIRST Topical AnalgesicLIDOCAINE HCIUltra Distributors Incb6f288f7-9ae3-215e-e053-2a95a90aedf62026-09-07WarningsExact identifier
ndc (package): 78495-142-01
ndc (product): 78495-142
ndc11 (package): 78495014201
spl id: 5aebcb33-8dcd-d9bc-e063-6294a90a555e
spl set id: b6f288f7-9ae3-215e-e053-2a95a90aedf6

Reported adverse events (FAERS/openFDA)#

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