FDA.reportPublic FDA data

CVS Extra Strength Itch Stopping Gel

Manufacturer
CVS | Weeks & Leo | weeks and Leo
Effective date
2025-11-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:43:36

Label at a glance#

ProductItch Stopping
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure9 sections

Storage and handling

store at 20 °C to 25 °C (68 °F to 77 °F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine hydrochloride 2%

INDICATIONS & USAGE SECTION

temporary relieves pain and itching due to:

insect bites

minor burns

sunburn

minor skin irritations

minor cuts

scrapes

rashes due to poison ivy, poison oak, and poison sumac

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

on large areas of the body

with any other product containing diphenhydramine, even one taken by mouth

OTC - ASK DOCTOR/PHARMACIST SECTION

On chiken Pox

On Measles

OTC - WHEN USING SECTION

do not get into eyes

OTC - STOP USE SECTION

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Anti itch

Topical analgesic

STORAGE AND HANDLING SECTION

store at 20 °C to 25 °C (68 °F to 77 °F)

INACTIVE INGREDIENT SECTION

camphor, citric acid, diazolidinyl urea, hypromellose, methylparaben, propylene glycol, propylparaben, purified water,
SD alcohol 40-B, sodium citrate

DOSAGE & ADMINISTRATION SECTION

do not use more often than directed

adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

children under 2 years: ask a doctor

RECENT MAJOR CHANGES SECTION

Dosage & Administration Section

Added- do not use more often than directed

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS health

Compare to the active ingredient in Benadryl Gel

Extra strength Itch Relief Gel

Diphenhydramine HCL 2%

Topical analgesic

Relives itching & pain associated with insect bites & rashes due to poison ivy, oak & sumac

For topical use only

ESISG .jpgESISG .jpgBack LabelBack Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049880diphenhydrAMINE HCl 2 % Topical GelPSN2
1049880diphenhydramine hydrochloride 0.02 MG/MG Topical GelSCD2
1049880diphenhydramine hydrochloride 2 % Topical GelSY2

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428410554GTIN-13: 0050428410554
EAN-13: 0050428410554
GTIN-12: 050428410554
UPC-A: 050428410554
GTIN storage (14 digits): 00050428410554		21-260v2.0 CVS Itch Gel Back Label .jpg

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
69842-620-04Itch Stopping113 g in 1 BOTTLEGEL1132

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
69842-62069842-620-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
TRISODIUM CITRATE DIHYDRATEB22547B95KIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
HYPROMELLOSE 2910 (4000 MPA.S)RN3152OP35IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12019-05-06full-release2026-05-31 22:59:25

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
Itch StoppingDIPHENHYDRAMINE HCLCVS8839149d-e6d5-57cc-e053-2995a90a98322025-11-12WarningsExact identifier
ndc (package): 69842-620-04
ndc (product): 69842-620
ndc11 (package): 69842062004
spl id: 436a99e7-ae1d-0fd5-e063-6394a90a75a3
spl set id: 8839149d-e6d5-57cc-e053-2995a90a9832