FDA.reportPublic FDA data

1% Hydrocortisone Anti-itch - ALAINA HEALTHCARE PRIVATE LIMITED

Manufacturer
ALAINA HEALTHCARE PRIVATE LIMITED
Effective date
2026-07-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-29 05:10:13

Label at a glance#

Product1% Hydrocortisone Anti-itch
Active ingredientHYDROCORTISONE
Label structure12 sections

Indications and uses

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

Dosage and administration

adults and children 2 years and over: apply to affected area not more than 3 to 4 times daily children under 2 years: ask a doctor for external anal and genital itching in adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroghly. 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 for...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

1% Hydrocortisone Anti-Itch Cream ​​​​​​​with Aloe Vera

Maximum Strength Cream

  • Inflamation & Redness
  • Skin Irritation & Rashes
  • Insects Bites, Poison Ivy
  • Eczema & Psoriasis

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                            Purpose

Hydrocortisone 1%........................................Anti-itch

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
    • eczema
    • seborrheic dermatitis
    • psoriasis
    • insect bites
    • poison ivy, poison oak, and poison sumac
    • cosmetics
    • jewelry
    • detergents
    • soaps
  • temporarily relieves external anal and genital 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. Ask a doctor.
  • for external genital itching if you have a vaginal discharge. Ask a doctor.

When using this product

OTC - WHEN USING SECTION

  • do not get into the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition gets worse, or if symptoms last for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product.
  • rectal bleeding occurs

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years and over:apply to affected area not more than 3 to 4 times daily
  • children under 2 years:ask a doctor
  • for external anal and genital itching in adults:
  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroghly.
  • 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
  • for external anal and genital itching in children under 12 years:ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at 20°c to 25°c (68°F to 77°F)

lnactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Ethylhexylglycerin, Glycerin, Glyceryl Monostearate, Light Liquid Paraffin, Petrolatum, Phenoxyethanol, Sodium Lauryl Sulfate, Water

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​​​​​​​1% Hydrocortisone Anti-Itch Cream ​​​​​​​with Aloe Vera
Maximum Strength Cream
Inflamation & Redness
​​​​​​​Skin Irritation & Rashes
Insects Bites, Poison Ivy
Eczema & Psoriasis

Net wt. 1 oz (28 g)

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Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73492-29173492-291-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
ALOE VERA LEAFZY81Z83H0XIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LIGHT MINERAL OILN6K5787QVPIACT
PETROLATUM4T6H12BN9UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM LAURYL SULFATE368GB5141JIACT
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
1% Hydrocortisone Anti-itch1% HYDROCORTISONE ANTI-ITCHALAINA HEALTHCARE PRIVATE LIMITEDb8416467-55f7-4e5f-a5cb-3abd3e2bb5772026-07-27WarningsExact identifier
ndc (package): 73492-291-28
ndc (product): 73492-291
ndc11 (package): 73492029128
spl id: 57979a5b-49cc-3ede-e063-6394a90a3254
spl set id: b8416467-55f7-4e5f-a5cb-3abd3e2bb577

Reported adverse events (FAERS/openFDA)#

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