FDA.reportPublic FDA data

Itch Relief Gel

Manufacturer
Walgreens | Unipack LLC
Effective date
2026-01-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:33:13

Label at a glance#

ProductItch Relief Gel
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure15 sections

Dosage and administration

Do not use more than directed. Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCL 2%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Use

INTENDED USE OF THE DEVICE

Temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor cuts, scrapes, minor skin irritations, rashes due to poison ivy, 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, even one taken by mouth

Ask a doctor before use 

OTC - ASK DOCTOR SECTION

on chicken pox,

on measles

When using this product

OTC - DO NOT USE SECTION

avoid contact with eyes

Stop use and ask a doctor if

OTC - ASK DOCTOR 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

INDICATIONS & USAGE SECTION

Do not use more than directed.

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

camphor, diazolidinyl urea, glycerin, hydroxypropyl methylcellulose, methylparaben, propylene glycol, propylparaben, purified water, SD alcohol 40-B, sodium citrate

Questions?

OTC - QUESTIONS SECTION

1-800-925-4733

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to affected area not more thatn 3 to 4 times daily

Tube label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube labelTube label

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-130311917195919GTIN-13: 0311917195919
EAN-13: 0311917195919
GTIN-12: 311917195919
UPC-A: 311917195919
GTIN storage (14 digits): 00311917195919		401534.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-0353-042024-02-20C16284748780-11030e365-5379-111a-e063-dadaa90a10e2Walgreens Itch Relief Gel
0363-0353-042024-01-30C16284748780-11030e365-5379-111a-e063-dadaa90a10e2Walgreens Itch Relief Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0353-04Itch Relief Gel103.5 mL in 1 TUBEGEL103.56

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
0363-03530363-0353-04

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
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
SODIUM CITRATE1Q73Q2JULRIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
ALCOHOL3K9958V90MIACT
HYPROMELLOSE 2208 (15000 MPA.S)Z78RG6M2N2IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB

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
Itch Relief GelDIPHENHYDRAMINE HCLWalgreens487060a7-dff3-4840-b967-ca919f8d0a292026-01-15WarningsExact identifier
ndc (package): 0363-0353-04
ndc (product): 0363-0353
ndc11 (package): 00363035304
spl id: 485ea50e-b62a-cbb9-e063-6394a90a1cdf
spl set id: 487060a7-dff3-4840-b967-ca919f8d0a29

Reported adverse events (FAERS/openFDA)#

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