FDA.reportPublic FDA data

49314-0003, Unishield First Aid & Burn Cream

Manufacturer
Unishield | Nantong Health & Beyond Hygienic Products Inc.
Effective date
2026-06-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-07-17 21:37:08

Label at a glance#

ProductFIRST SHIELD
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

OTC - STOP USE SECTION

  • Stop use and ask a doctor ifthe condition worsens or if symptom 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 affected area, apply a small amount not more than 3-4 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, PEG-100 Stearate, phenoxyethanol, stearic acid, sodium hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
49314-0003-22025-01-30C16284748780-12cef2736-b482-d83d-e063-dadaa90ab31fUnishield First Aid & Burn Cream
49314-0003-22025-01-30C16284748780-12cef2736-b482-d83d-e063-dadaa90ab31f49314-0003, Unishield First Aid & Burn Cream

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49314-000349314-0003-1, 49314-0003-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12023-04-03full-release2026-05-31 23:54:38

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
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIUnishieldf86f7446-b741-9f40-e053-6394a90a44222026-06-29WarningsExact identifier
ndc (package): 49314-0003-2
ndc (package): 49314-0003-1
ndc (product): 49314-0003
ndc11 (package): 49314000301
ndc11 (package): 49314000302
spl id: 555e62d4-316e-bef1-e063-6294a90abece
spl set id: f86f7446-b741-9f40-e053-6394a90a4422

Reported adverse events (FAERS/openFDA)#

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