FDA.reportPublic FDA data

Anti Itch

Manufacturer
Neilmed Pharmaceuticals Inc.
Effective date
2025-03-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:56:55

Label at a glance#

ProductAnti Itch
Active ingredientHYDROCORTISONE
Label structure11 sections

Indications and uses

Temporarily alleviates itching associated with minor skin irritation, inflammation and rashes due to: Eczema Poison ivy, oak and sumac Psoriasis Soaps and detergents Cosmetics Jewelry Insect bites Seborheic dermatitis

Dosage and administration

Shake well 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 - to apply to face, spray into palm of hand and gently apply

Label contents#

Full prescribing information#

DRUG FACTS - Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1.0%

Purpose

OTC - PURPOSE SECTION

Anti-Itch

Uses

INDICATIONS & USAGE SECTION

Temporarily alleviates itching associated with minor skin irritation, inflammation and rashes due to:

  • Eczema
  • Poison ivy, oak and sumac
  • Psoriasis
  • Soaps and detergents
  • Cosmetics
  • Jewelry
  • Insect bites
  • Seborheic dermatitis

Warnings

WARNINGS SECTION

For external use only.
Flammable: Do not use while smoking or near heat or flame

Warnings : Do not use:

OTC - DO NOT USE SECTION

In or near the eyes; for diaper rash ask a doctor. In case of an accidental exposure rinse with water or saline immediately, remove contact lenses and sesk medical help for any persistent symptoms. Use only as directed. Do not puncture or incinerate. Contents under pressure. Avoid long term storage above 104°F. Do not store at temperatures above 120°F.

Warnings : Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you are using any other hydrocortisone or corticosteroid product.

Warnings : Stop use and ask doctor

OTC - STOP USE SECTION

if condition worsens or does not improve within 7 days, or clears up and occurs again within a few days.

Warnings: 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. 1-800-222-1222

Directions:

DOSAGE & ADMINISTRATION SECTION

Shake well

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 - to apply to face, spray into palm of hand and gently apply

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 407, Polysorbate 20, SD Alcohol 40-B, USP grade purified Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens Anti Itch sprayWalgreens Anti Itch spray

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
317564hydrocortisone 1 % Topical SprayPSN1
317564hydrocortisone 10 MG/ML Topical SpraySCD1
317564hydrocortisone 1 % Topical SpraySY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
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a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
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36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
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abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
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fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-327-01Anti Itch1 in 1 CARTONSPRAY11
13709-327-01Anti Itch90 g in 1 CANSPRAY901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-327ANTI ITCH SPRAY [NEILMED PHARMACEUTICALS INC.]1Current NDC, 2 package rows20250312_2fa74baf-e3d2-e099-e063-6394a90a1bae.zip

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
13709-32713709-327-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
WATER059QF0KO0RIACT
POLOXAMER 407TUF2IVW3M2IACT
EDETATE DISODIUM7FLD91C86KIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 207T1F30V5YHIACT
HYDROCORTISONEWI4X0X7BPJACTIB

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
Anti ItchANTI ITCHNeilmed Pharmaceuticals Inc.2fa74baf-e3d2-e099-e063-6394a90a1bae2025-03-06WarningsExact identifier
ndc (package): 13709-327-01
ndc (product): 13709-327
ndc11 (package): 13709032701
spl id: 2fa74baf-e3d3-e099-e063-6394a90a1bae
spl set id: 2fa74baf-e3d2-e099-e063-6394a90a1bae

Reported adverse events (FAERS/openFDA)#

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