FDA.reportPublic FDA data

CVS Instant Cooling Itch Relief Spray

Manufacturer
CVS Pharmacy
Effective date
2026-08-07
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-08-11 01:01:11

Label at a glance#

ProductInstant Cooling Itch Relief
Active ingredientHYDROCORTISONE
Label structure8 sections

Indications and uses

temporarily relieves itching associated with minor skin irritation, inflammation and rashes due to: eczema psoriasis insect bites poison ivy, oak, and sumac soaps and detergents seborrheic dermatitis cosmetics jewelry other use of this product hsould only be under the advice and supervision of a doctor

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 to apply to face, spray into palm of hand and gently apply children under 2 years of age: Do not use, ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

temporarily relieves itching associated with minor skin irritation, inflammation and rashes due to:

  • eczema
  • psoriasis
  • insect bites
  • poison ivy, oak, and sumac
  • soaps and detergents
  • seborrheic dermatitis
  • cosmetics
  • jewelry
  • other use of this product hsould only be under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only.

Flammable: Do not use while smoking or near heat or flame

Do not use

WARNINGS SECTION

  • in or near eyes
  • for the treatment of diaper rash, consult a doctor

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with warm water to remove.
  • contents under pressure
  • do not puncture or incinerate.
  • use only as directed
  • do not use more than directed unless told to do so by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens or does not improve within 7 days
  • 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

If pregnant or breast-feeding

PREGNANCY SECTION

ask a health professional before use.

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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
    • to apply to face, spray into palm of hand and gently apply
    • children under 2 years of age: Do not use, ask a doctor

Other information

OTHER SAFETY INFORMATION

  • May cause staining. Use with caution when spraying near fabrics and unprotected surfaces. Store between 20° to 25°C (68° to 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Principal Display Panel - 85 g Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 51316-388-03

CVS TM

Instant Cooling

ITCH RELIEF

SPRAY

Hydrocortisone 1%

Intensive Therapy

Compare to Cortizone-10 ®

Cooling Spray active ingredient*

Sprays at Any Angle

NET WT 3 OZ (85 g)

Can labelCan label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
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626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
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a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
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fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
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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
51316-38851316-388-03

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
HYDROCORTISONEWI4X0X7BPJACTIB
POLOXAMER 188LQA7B6G8JGIACT
EDETATE DISODIUM7FLD91C86KIACT
POLYSORBATE 207T1F30V5YHIACT
ALCOHOL3K9958V90MIACT
CITRIC ACID2968PHW8QPIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-12-19full-release2026-06-01 01:27:48

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
Instant Cooling Itch ReliefHYDROCORTISONECVS Pharmacy46545d04-5958-d136-e063-6394a90a34622026-08-07WarningsExact identifier
ndc (package): 51316-388-03
ndc (product): 51316-388
ndc11 (package): 51316038803
spl id: 58768236-8a96-e101-e063-6394a90ad9e0
spl set id: 46545d04-5958-d136-e063-6394a90a3462

Reported adverse events (FAERS/openFDA)#

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