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Xpect First Aid Cream

Xpect First Aid Cream

Approved
Approval ID

f7112e5d-c8c4-42ad-8a65-24bfc32d4aea

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 30, 2025

Manufacturers
FDA

Cintas Corporation

DUNS: 056481716

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Benzalkonium Chloride, Lidocaine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42961-259
Application NumberM003
Product Classification
M
Marketing Category
C200263
G
Generic Name
Benzalkonium Chloride, Lidocaine HCl
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 30, 2025
FDA Product Classification

INGREDIENTS (11)

BENZALKONIUM CHLORIDEActive
Quantity: .13 g in 100 g
Code: F5UM2KM3W7
Classification: ACTIB
LIDOCAINE HCLActive
Quantity: .5 g in 100 g
Code: V13007Z41A
Classification: ACTIR
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
PARAFFINInactive
Code: I9O0E3H2ZE
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
WHITE WAXInactive
Code: 7G1J5DA97F
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/30/2025

Principal Display Panel

FIRST AID CREAM

Active Ingredients:

Benzalkonium Chloride 0.13%

Lidocaine HCl 0.5%

First Aid Antiseptic and Topical Analgesic

First aid to help prevent infection in minor cuts, scrapes, and burns.

Xpect® First aid

Distributed by: Cintas® • Mason, OH 45040 • www.cintas.com

NET WT. PER PACKET 1/32 OZ (0.9g)

20 Packets per Box

Box20

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/30/2025

Uses

  • temporary relief of pain associated with minor cuts, scrapes, and burns
  • helps protect against harmful bacteria

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 9/30/2025

Active ingredients

Benzalkonium chloride 0.13%

Lidocaine HCl 0.5%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 9/30/2025

Purpose

First aid antiseptic

Topical analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 9/30/2025

Warnings

For external use only.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 9/30/2025

Do not use

  • in 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.

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 9/30/2025

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 9/30/2025

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/30/2025

Directions

  • adults and children 2 years and over: clean affected area, apply small amount no more than 3 times daily, may be covered with a sterile bandage
  • children under 2 years: do not use, consult a doctor

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 9/30/2025

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 9/30/2025

Inactive ingredients

aloe vera, cetearyl alcohol*, disodium EDTA*, emulsifying wax*, ethyl alcohol*, ethylhexylglcerin*, glycerin*, glyceryl stearate/PEG100 stearate*, maltodextrin*, methylparaben*, mineral oil, paraffin*, phenoxyethanol*, propylene glycol*, propylparaben*, purified water, stearic acid*, sodium hydroxide*, white petrolatum*, white wax*

  • may contain ingredient

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 9/30/2025

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