FDA.reportPublic FDA data

First Aid Antiseptic

Manufacturer
Premier Value | Product Quest Mfg
Effective date
2018-07-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:13

Label at a glance#

ProductFirst Aid Antiseptic
Active ingredientLIDOCAINE HYDROCHLORIDE, BENZALKONIUM CHLORIDE
Label structure7 sections

Indications and uses

First aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor: cuts, scrapes, burns, sunburn, skin irritations

Dosage and administration

• Adults and children 2 years and older: clean the affected area. Apply small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first) • Children Under 2 years: Consult a physician.

Label contents#

Full prescribing information#

Active ingredients                   Purpose

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium 0.13%                First Aid Antiseptic

Lidocaine HCl 2.5%                 Pain Relieving Spray

OTC - PURPOSE SECTION

Uses

INDICATIONS & USAGE SECTION

First aid to help prevent bacterial contamination or skin infection, and for temporary relief of pain and itching associated with minor: cuts, scrapes, burns, sunburn, skin irritations

Warnings

WARNINGS SECTION

​ ​For external use only

​Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

When using this product​

OTC - WHEN USING SECTION

  • do not use in or near the eyes
  • do not apply over large area of the body or in large quantities
  • do not apply over raw surfaces or blistered areas

​Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • 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 swallowed get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

• Adults and children 2 years and older: clean the affected area. Apply small amount on the area 1-3 times daily; may be covered with a sterile bandage (let dry first) • Children Under 2 years: Consult a physician.

Other information

OTHER SAFETY INFORMATION

Avoid excessive heat

Inactive ingredients

INACTIVE INGREDIENT SECTION

Diazolidinyl Urea, Disodium EDTA, Fragrance, Methylparaben, Nonoxynol 9, Propylene Glycol, Propylparaben, Sodium Phosphate Dibasic, Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012099benzalkonium Cl 0.13 % / lidocaine HCl 2.5 % Topical SprayPSN1
1012099benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 25 MG/ML Topical SpraySCD1
1012099benzalkonium Cl 0.13 % / lidocaine HCl 2.5 % Topical SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE 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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-269-012020-01-31C16284748780-19d75b9d0-0a51-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-269-01First Aid Antiseptic148 mL in 1 BOTTLESPRAY1481

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-269FIRST AID ANTISEPTIC (BENZALKONIUM 0.13%, LIDOCAINE HCL 2.5%) SPRAY [PREMIER VALUE]1Legacy NDC, 1 package rows20180711_44c67780-a53a-422d-bc7e-c7720205be00.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-269-01ML - Milliliter68016-269303651a7-1f44-42e2-833f-74e5ef019ef612022-06-06

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
68016-26968016-269-01

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
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
Diazolidinyl UreaH5RIZ3MPW4IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
MethylparabenA2I8C7HI9TIACT
NONOXYNOL-948Q180SH9TIACT
Propylene Glycol6DC9Q167V3IACT
PropylparabenZ8IX2SC1OHIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
Water059QF0KO0RIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a0f157b6-aa0e-4879-9be8-a377902b8f9744c67780-a53a-422d-bc7e-c7720205be002018-07-10WarningsExact identifier
spl id: a0f157b6-aa0e-4879-9be8-a377902b8f97
spl set id: 44c67780-a53a-422d-bc7e-c7720205be00

Reported adverse events (FAERS/openFDA)#

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