FDA.reportPublic FDA data

Xpect Extra Strength Itch Relief

Manufacturer
Cintas Corporation | Safetec of America, Inc
Effective date
2025-09-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:14:44

Label at a glance#

ProductXpect Extra Strength Itch Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

for temporary relief of pain and itching associated with minor skin irritations and rashes due to insect bites, poison oak and poison sumac

Dosage and administration

do not use more than directed adults & children 12 years and over: apply to affected area not more than 3 to 4 times daily children under 12: consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 2%

Purpose

OTC - PURPOSE SECTION

   External Analgesic

Uses

INDICATIONS & USAGE SECTION

for temporary relief of pain and itching associated with minor skin irritations and rashes due to insect bites, poison oak and poison sumac

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on large areas of the body
  • with any other product containing diphenhydramine hydrochloride, even one taken by mouth

Ask a doctor before use

OTC - ASK DOCTOR SECTION

  • on chicken pox
  • on measles

When using this produt

OTC - WHEN USING SECTION

  • avoid contact with the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens symptoms persist 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

  • do not use more than directed
  • adults & children 12 years and over: apply to affected area not more than 3 to 4 times daily
  • children under 12: consult a doctor

​Other information

OTHER SAFETY INFORMATION

  • store at room temperature

Inactive Ingredients

INACTIVE INGREDIENT SECTION

germaben II, edetate disodium, glycerin, tomadol 25-9, purified water, triethanolamine

Questions?

OTC - QUESTIONS SECTION

1-877-973-2811 M-F 8am-5pm

Package Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Extra Strength

ITCH RELIEF

Quick Itch & Pain Relief

Diphenhydramine HCl 2%

Convenient pump spray allows no-touch  application. Use as a  first aid treatment for  insect bites and  rashes from poison  ivy, oak & sumac. 

2 fl. oz. (59.1 mL)

Xpect® First aid

BottleBottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1050080diphenhydrAMINE HCl 2 % Topical SprayPSN4
1050080diphenhydramine hydrochloride 20 MG/ML Topical SpraySCD4
1050080diphenhydramine HCl 2 % Topical SpraySY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIPHENHYDRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42961-218-01Xpect Extra Strength Itch Relief59.1 mL in 1 BOTTLE, SPRAYSPRAY59.14

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42961-21842961-218-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
C12-15 PARETH-9H3ZIY6WP1RIACT
water059QF0KO0RIACT
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
Xpect Extra Strength Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDECintas Corporationa373b2c3-5c58-4b64-9358-bdf42dfce08c2025-09-24WarningsExact identifier
ndc (package): 42961-218-01
ndc (product): 42961-218
ndc11 (package): 42961021801
spl id: 43b08582-e9bb-4ba4-a2ca-7eab3c9c16c6
spl set id: a373b2c3-5c58-4b64-9358-bdf42dfce08c

Reported adverse events (FAERS/openFDA)#

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