NeilMed Anti-Itch Spray

Manufacturer
NeilMed Pharmaceuticals Inc. | NeilMed Pharmaceuticals, Inc.
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:04

Label at a glance#

ProductNeilMed Anti-Itch
Active ingredientHYDROCORTISONE
Label structure8 sections

Indications and uses

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

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

Warnings:

WARNINGS SECTION

For external use only.
Flammable: Do not use while smoking or near heat or flame
Do not use: 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 seek 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
Ask a doctor before use if you are using any other hydrocortisone or corticosteroid product.
Stop use and ask doctor if condition worsens or does not improve within 7 days, or clears up and occurs again within a few days.
Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

Uses:

INDICATIONS & USAGE SECTION

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

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

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.

Drug Facts: Purpose

OTC - PURPOSE SECTION


Anti-itch

Drug Facts:

OTC - ACTIVE INGREDIENT SECTION


Active Ingredient
Hydrocortisone 1.0%

NeilMed Anti Itch Spray

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NeilMed Anti-Itch SprayNeilMed Anti-Itch Spray

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-239-01NeilMed Anti-Itch90 g in 1 CANSPRAY903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-239NEILMED ANTI-ITCH (ANTI-ITCH SPRAY) SPRAY [NEILMED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 1 package rows20240112_b3d34d9e-85d9-df4e-e053-2a95a90ac8d9.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
13709-23913709-239-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

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
NeilMed Anti-ItchANTI-ITCH SPRAYNeilMed Pharmaceuticals Inc.b3d34d9e-85d9-df4e-e053-2a95a90ac8d92024-01-11WarningsExact identifier
ndc (package): 13709-239-01
ndc (product): 13709-239
ndc11 (package): 13709023901
spl id: 0eb0a47d-4c98-a632-e063-6394a90a29dd
spl set id: b3d34d9e-85d9-df4e-e053-2a95a90ac8d9

Reported adverse events (FAERS/openFDA)#

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