FDA.reportPublic FDA data

Xpect First Aid Cream

Manufacturer
Shares Inc
Effective date
2022-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:30

Label at a glance#

ProductXpect First Aid Cream
Active ingredientBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE
Label structure13 sections

Indications and uses

first aid to help prevent infection and for the temporary relief of pain in minor cuts, scrapes and burns

Dosage and administration

adults and children 2 years of age and older clean the affected area may be covered with a sterile bandage apply a small amount (an amount equal to the surface area of the tip of finger) 1 to 3 times daily

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzalkonium chloride 0.13%

Lidocaine HCL 0.5%

Purpose

OTC - PURPOSE SECTION

First aid antiseptic

External analgesic

Uses

INDICATIONS & USAGE SECTION

first aid to help prevent infection and for the temporary relief of pain in minor cuts, scrapes and burns

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes or apply over large areas of the body
  • longer than 1 week unless directed by a doctor
  • in large quantitites, particularly over raw surfaces or blistered areas

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition persists or gets worse

  • symptoms persist for more than 7 days
  • condition clears up and occurs again within a few days
  • a rash or other allergic reaction develops

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 of age and older

  • clean the affected area
  • may be covered with a sterile bandage
  • apply a small amount (an amount equal to the surface area of the tip of finger) 1 to 3 times daily

Other information

OTHER SAFETY INFORMATION

  • do not use if packet is torn, cut or opened
  • store at room temperature (do not freeze)
  • see packet for Lot Number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, cetyl alcohol, diazolidinyl urea, edetate disodium, glycerin, glyceryl monosterate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

Questions

OTC - QUESTIONS SECTION

1-877-973-2811

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

First Aid Cream

Antixeptic and pain reliever

Net Wt per Pkt 1.32 oz (0.9 g)

20 pkts per box

Front PanelFront Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1012100benzalkonium chloride 0.13 % / lidocaine HCl 0.5 % Topical CreamPSN1
1012100benzalkonium chloride 1.3 MG/ML / lidocaine hydrochloride 5 MG/ML Topical CreamSCD1
1012100benzalkonium chloride 0.13 % / lidocaine hydrochloride 0.5 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
82940-214-012023-07-28C16284748780-10191ceaa-6ecd-198a-e063-dbdaa90aec3expect first aid cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82940-214-01Xpect First Aid Cream20 in 1 BOXCREAM201
82940-214-01Xpect First Aid Cream0.9 g in 1 PACKETCREAM0.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82940-214XPECT FIRST AID CREAM (BENZALKONIUM CHLORIDE, LIDOCAINE HCL) CREAM [SHARES INC]1Legacy NDC, 2 package rows20220823_e6a00aa3-281f-104a-e053-2995a90adfaf.zip

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
82940-21482940-214-01
42961-214

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
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MINERAL OILT5L8T28FGPIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
CETYL ALCOHOL936JST6JCNIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
TROLAMINE9O3K93S3TKIACT

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
e6a00aa3-2820-104a-e053-2995a90adfafe6a00aa3-281f-104a-e053-2995a90adfaf2022-08-19WarningsExact identifier
spl id: e6a00aa3-2820-104a-e053-2995a90adfaf
spl set id: e6a00aa3-281f-104a-e053-2995a90adfaf

Reported adverse events (FAERS/openFDA)#

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