FDA.reportPublic FDA data

Itch Relief Gel

Manufacturer
Pharma Nobis, LLC
Effective date
2023-12-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:05:33

Label at a glance#

ProductItch Relief Gel
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Do not use more often than directed.

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

Children under 2 years of age: ask a doctor.

WARNINGS SECTION

For external use only.

INACTIVE INGREDIENT SECTION

Camphor, Citric Acid, Diazolidnyl Urea, Glycerin, Hydroxypropyl Methylcellulose, Methylparaben, Propylene Glycol, Propylparaben, SD Alcohol 38-B, Sodium Citrate, Purified Water.

INDICATIONS & USAGE SECTION

Temporarily relieves pain due to: Minor burns, insect bites, sunburn, minor skin irritation, minor cuts, scrapes, rashes due to poison ivy, poison oak and poison sumac.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

External Analgesic

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 2%

Equate Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

itchgelitchgel [

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
82645-901-94Itch Relief Gel118 mL in 1 CONTAINERGEL1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82645-901ITCH RELIEF GEL GEL [PHARMA NOBIS, LLC]2Current NDC, Legacy NDC, 1 package rows20231223_e42f484d-a641-3489-e053-2a95a90a4254.zip

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
82645-90182645-901-94

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
ALCOHOL3K9958V90MIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
SODIUM CITRATE1Q73Q2JULRIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
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 GelITCH RELIEF GELPharma Nobis, LLCe42f484d-a641-3489-e053-2a95a90a42542023-12-22WarningsExact identifier
ndc (package): 82645-901-94
ndc (product): 82645-901
ndc11 (package): 82645090194
spl id: 0d1cd578-e127-6e8e-e063-6294a90a5060
spl set id: e42f484d-a641-3489-e053-2a95a90a4254

Reported adverse events (FAERS/openFDA)#

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