Hydrocortisone USP 1% Lotion

Manufacturer
AKRON PHARMA INC
Effective date
2026-07-22
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-07-25 05:10:29

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure13 sections

Dosage and administration

Shake will before using. For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily. For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1% (Micronized)

Purpose

OTC - PURPOSE SECTION

Antipruritic (Anti-itch)

Use

INDICATIONS & USAGE SECTION

For the temporary relief of minor skin irritations, inflammations, itching and rashes caused by:

  • insect bites
  • eczema
  • psoriasis
  • soaps
  • detergents
  • cosmetics,
  • jewelry,
  • poison oak,
  • poison sumac
  • Other uses of this product should be undertaken only under the advice and supervision of a doctor.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

Do not get into eyes. If contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Condition worsens
  • If symptoms persist for more than 7 days or clear up and occur again within a few days. Discontinue use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.
  • Do no use for diaper rash. Consult a doctor.

Keep out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake will before using.
  • For adults and children 2 years of age and older: Apply to affected area not more than 2 to 4 times daily.
  • For children under 2 years of age: there is no recommended dosage except under the advice and supervision of a doctor.

Other Information

OTHER SAFETY INFORMATION

• Store away from excessive heat or cold.  Shake well before using.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water, Glycerin, Cetyl Alcohol, Benzyl Alcohol, Sodium Lauryl Sulfate, Stearyl Alcohol, Aloevera, Xanthan Gum

Questions?

OTC - QUESTIONS SECTION

Please Call 1(877) 225-6999

SPL UNCLASSIFIED SECTION

Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ 07004

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1122

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0120-1ML - Milliliter71399-0120eb79b715-e523-40be-b78c-e8424944712b12019-06-19

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
71399-012071399-0120-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82026-07-07weekly-update2026-07-17 21:43:52
72026-01-12full-release2026-06-01 01:32:47

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
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCdaad9a1e-98d2-4ce7-9d97-ac5d81905abb2026-07-22WarningsExact identifier
ndc (package): 71399-0120-1
ndc (product): 71399-0120
ndc11 (package): 71399012001
spl id: 5739d1f7-66e8-69d4-e063-6294a90a5f9a
spl set id: daad9a1e-98d2-4ce7-9d97-ac5d81905abb

Reported adverse events (FAERS/openFDA)#

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