FDA.reportPublic FDA data

AEROSOOTHE Hydrocortisone Cream

Manufacturer
Aero Healthcare US LLC
Effective date
2026-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-28 05:10:11

Label at a glance#

ProductAEROSOOTHE
Active ingredientHYDROCORTISONE
Label structure13 sections

Indications and uses

for temporary relief of itching associated with minor skin irritations and rashes for external genital, feminine, and anal itching other uses of this product should be only under the advice and supervision of a doctor

Dosage and administration

For itching or skin irritation, inflammation, and rashes: 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: do not use unless directed by a doctor For external anal and genital itching, Adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tis...

Storage and handling

store at 20° - 25°C (68° - 77°F) tamper evident, do not use if packet is torn, cut or opened avoid excessive heat and humidity

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Antipruritic (anti-itch)

Uses

INDICATIONS & USAGE SECTION

  • for temporary relief of itching associated with minor skin irritations and rashes
  • for external genital, feminine, and anal itching
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

  • for the treatment of diaper rash, consult a doctor
  • with any other hydrocortisone product unless you have consulted a doctor
  • if you have a vaginal discharge, consult a doctor

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not put this product into rectum by using fingers, mechanical device or applicator
  • do not exceed recommended daily dosage unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product
  • rectal bleeding occurs

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • For itching or skin irritation, inflammation, and rashes: 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: do not use unless directed by a doctor
  • For external anal and genital itching, Adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily

Other information

STORAGE AND HANDLING SECTION

  • store at 20° - 25°C (68° - 77°F)
  • tamper evident, do not use if packet is torn, cut or opened
  • avoid excessive heat and humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

Ceteareth-20, Cetearyl alcohol, Ethylhexylglycerin, Glycerin, Glyceryl stearate, Mineral oil, Petrolatum, Phenoxyethanol, Water.

Questions?

OTC - QUESTIONS SECTION

Call 1-845-618-7037

PRINCIPAL DISPLAY PANEL - 25 Packet Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AERO SOOTHE™

HYDROCORTISONE CREAM

temporary relief of itching

Hydrocortisone 1%

Soothing

Single Use Packets

25

0.9g / 1/32oz

PULL UP AND TEAR OFF TO DISPENSE

AERO Healthcare - HEALTHCARE, WE MAKE IT BETTER

Manufactured for AERO HEALTHCARE US Valley Cottage, NY, 10989

www.aerohealthcare.us.com

MADE IN CHINA

Do not use if packaging is damaged or opened.

THIS PRODUCT IS NOT A SUBSTITUTE FOR PROFESSIONAL ATTENTION FROM A HEALTHCARE PRACTITIONER.

REF Code ASH0925

V1.ASH0925.BX

AEROSOOTHE Hydrocortisone Cream 1% cartonAEROSOOTHE Hydrocortisone Cream 1% carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-139341394039698GTIN-13: 9341394039698
EAN-13: 9341394039698
GTIN storage (14 digits): 09341394039698		55305-136_carton_artwork.jpg

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55305-13655305-136-01, 55305-136-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT

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
AEROSOOTHEHYDROCORTISONEAero Healthcare US LLC22b172a2-07e8-4ebb-b0a0-dfe4f25477fa2026-07-24WarningsExact identifier
ndc (package): 55305-136-01
ndc (package): 55305-136-02
ndc (product): 55305-136
ndc11 (package): 55305013602
ndc11 (package): 55305013601
spl id: 5760972d-3a2d-f14f-e063-6294a90a836a
spl set id: 22b172a2-07e8-4ebb-b0a0-dfe4f25477fa

Reported adverse events (FAERS/openFDA)#

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