FDA.reportPublic FDA data

Meijer Hydrocortisone Spray

Manufacturer
Meijer Distribution Inc.
Effective date
2024-10-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 20:52:35

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure8 sections

Indications and uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: eczema insect bites poison ivy poison oak poison sumac soaps jewelry detergents cosmetics seborrheic dermatitis psoriasis other uses of this product should be only under the advice and supervision of a doctor

Dosage and administration

twist cap counterclockwise to unlock actuator adults and children 2 years of age and older: spray affected area not more than 3 to 4 times daily children under 2 years of age: do not use, consult a doctor to apply to face, spray into palm of hand and gently apply

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

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

Warnings

WARNINGS SECTION

For external use only.

Flammable:

SAFE HANDLING WARNING SECTION

Keep away from heat, sparks and open flame. Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120 ºF. Intentional misuse by deliberately concentrating and inhaling contents can be harmful or fatal.

Do not use

OTC - DO NOT USE SECTION

  • for external genital, vaginal or anal itching
  • with other hydrocortisone product unless directed by a doctor
  • in or near the eyes
  • for diaper rash

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • if product gets into the eye, flush with water for 15 minutes

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 and do not begin use of any other hydrocortisone product unless you have consulted a doctor

Keep out of the reach of children.

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

  • twist cap counterclockwise to unlock actuator
  • adults and children 2 years of age and older: spray affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, consult a doctor
  • to apply to face, spray into palm of hand and gently apply

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, disodium EDTA, ethoxydiglycol, glycerin, maltodextrin, menthyl lactate, methyl gluceth-20, PEG-8, SD alcohol 40-B, sodium citrate, water

Questions ?

OTC - QUESTIONS SECTION

Call 1-866-964-0939

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

meijer

CONTINUOUS

hydrocortisone

spray

HYDROCORTISONE 1% / ANTI-ITCH

Relieves Itching

Maximum Strength

Relieves itching from

rashes, irritation,

insect bites &

poison ivy,

oak & sumac

No-touch & no-mess

NET WT 4.0 0Z (113 g)

hydrocortisone sprayhydrocortisone spray

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-290HYDROCORTISONE (HYDROCORTISONE CONTINUOUS SPRAY) AEROSOL, SPRAY [MEIJER DISTRIBUTION INC.]5Legacy NDC20241016_b35f5395-fff8-2ce0-e053-2a95a90a3a1c.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41250-29041250-290-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
EDETATE DISODIUM7FLD91C86KIACT
MENTHYL LACTATE, (-)-2BF9E65L7IIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM CITRATE1Q73Q2JULRIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALOE VERA LEAFZY81Z83H0XIACT
METHYL GLUCETH-20J3QD0LD11PIACT
OATZ6J799EAJKIACT
WATER059QF0KO0RIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
ALCOHOL3K9958V90MIACT
MALTODEXTRIN7CVR7L4A2DIACT

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
247a1fb6-8aa9-0114-e063-6394a90aa034b35f5395-fff8-2ce0-e053-2a95a90a3a1c2024-10-14WarningsExact identifier
spl id: 247a1fb6-8aa9-0114-e063-6394a90aa034
spl set id: b35f5395-fff8-2ce0-e053-2a95a90a3a1c

Reported adverse events (FAERS/openFDA)#

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