Cooling Itch Spray

Manufacturer
NeilMed Pharmaceuticals, Inc
Effective date
2020-04-08
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 23:36:57

Label at a glance#

ProductCooling Itch Relief
Active ingredientHYDROCORTISONE
Label structure12 sections

Indications and uses

Temporarily relieves itching associated with minorskin irritation and rashes due to:• eczema • poison ivy, oak and sumac • cosmetics• psoriasis • soaps and detergents • jewelry• insect bites • seborrheic dermatitis

Dosage and administration

See Attached Image File Principal Display Panel Anti Itch Spray

Label contents#

Full prescribing information#

OTC Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1% Anti itch

Principal Display Panel Anti Itch Spray.jpg

USES

OTC - PURPOSE SECTION

Temporarily relieves itching associated with minorskin irritation and rashes due to:• eczema • poison ivy, oak and sumac • cosmetics• psoriasis • soaps and detergents • jewelry• insect bites • seborrheic dermatitis

WARNINGS

WARNINGS SECTION

For external use only

DO NOT USE

OTC - DO NOT USE SECTION

• in or near the eyes • for external genital • vaginal or anal itching • for diaper rash: ask a doctor

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

• Keep out of eyes. Rinse with water to remove • Use only as directed. • Do not puncture or incinerate. Contents under pressure• Do not store at temperature above 120F

STOP USE AND ASK A DOCTOR IF

OTC - STOP USE SECTION

• condition worsens or does not improve withing 7 days• symptomspersist more than 7 days or clear up and occur again within a few days

KEEP OUT OF REACH OF THE CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 188, Polysorbate 20, SD Alcohol 40-B, Water

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

See Attached Image File Principal Display Panel Anti Itch Spray

Indication & Usage

INDICATIONS & USAGE SECTION

For the temporary relief of itching associated with minor
skin irritation and rashes due to: • eczema • poison ivy, oak and
sumac • cosmetics • jewelry • soaps and detergents • insect
bites. Other uses of this product should be only under the advice
and supervision of a doctor.

Warnings
For external use only.
Flammable: Keep away from fire or flame
Avoid contact with the eyes. If condition worsens, or if symptoms
persist for more than 7 days or clear up and occur again within a
few days, stop use of this product and do not begin use of any
other hydrocortisone product unless you have consulted a doctor.
Do not use for the treatment of diaper rash. Consult a doctor.
Do not puncture or incinerate. Contents under pressure. Do not
store at temperatures above 120˚F

OTC - Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of the children

If swallowed, get medical help or contact a Poison Control Center right away

Package.Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package.Label Principal Display Panel

Principle Display PanelPrinciple Display Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13710-310-032020-02-14C16284748780-19d75b9cf-cdc4-f424-e053-dadaa90a57ceCooling Itch Spray
13710-310-032020-01-31C16284748780-19d75b9cf-cdc4-f424-e053-dadaa90a57ceCooling Itch Spray

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13710-31013710-310-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
GLYCERINPDC6A3C0OXIACT

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
a2c3cbc9-fe74-5db6-e053-2995a90a0ee57b3377cf-183d-7ace-e053-2a91aa0a1bfe2020-04-08WarningsExact identifier
spl id: a2c3cbc9-fe74-5db6-e053-2995a90a0ee5
spl set id: 7b3377cf-183d-7ace-e053-2a91aa0a1bfe

Reported adverse events (FAERS/openFDA)#

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