FDA.reportPublic FDA data

Itch Relief

Manufacturer
Neilmed Pharmaceuticals Inc.
Effective date
2025-11-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:21:14

Label at a glance#

ProductItch Relief
Active ingredientDIPHENHYDRAMINE HYDROCHLORIDE
Label structure14 sections

Indications and uses

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

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 Children under 2 years of age: ask a doctor

Storage and handling

Store at Room Temperature

Label contents#

Full prescribing information#

Drug Facts: Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Diphenhydramine HCl 2%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE 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 If

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

swallowed, get medical help or contact a Poison Control Center right away, 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION 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
  • Children under 2 years of age: ask a doctor

Other Information

STORAGE AND HANDLING SECTION

Store at Room Temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • Camphor
  • diazolidinyl urea
  • glycerin
  • hydroxyethyl cellulose
  • methylparaben
  • propylene glycol
  • propylparaben
  • purified water
  • SD alcohol 40-B
  • sodium citrate

Tamper Evident

OTHER SAFETY INFORMATION

Do not use if seal on tube is punctured or missing

Questions?

OTC - QUESTIONS SECTION

1(877) 477-8633

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Itch ReliefItch Relief

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1049880diphenhydrAMINE HCl 2 % Topical GelPSN1
1049880diphenhydramine hydrochloride 0.02 MG/MG Topical GelSCD1
1049880diphenhydramine hydrochloride 2 % Topical GelSY1

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
13709-351-01Itch Relief1 in 1 CARTONGEL11
13709-351-01Itch Relief103.5 mL in 1 TUBEGEL103.51

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
13709-35113709-351-01

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
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40ACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)8136Y38GY5IACT
WATER059QF0KO0RIACT
PROPYLPARABENZ8IX2SC1OHIACT
ALCOHOL3K9958V90MIACT

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 ReliefITCH RELIEF GELNeilmed Pharmaceuticals Inc.44811828-c32e-17fc-e063-6294a90add482025-11-26WarningsExact identifier
ndc (package): 13709-351-01
ndc (product): 13709-351
ndc11 (package): 13709035101
spl id: 44811828-c32f-17fc-e063-6294a90add48
spl set id: 44811828-c32e-17fc-e063-6294a90add48

Reported adverse events (FAERS/openFDA)#

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