NeilMed Hydrocortisone 1% Cream with Aloe Anti-Itch

Manufacturer
NeilMed Pharmaceuticals Inc.
Effective date
2024-07-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:14:56

Label at a glance#

ProductHydrocortisone with aloe
Active ingredientHYDROCORTISONE
Label structure13 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 ■ psoriasis ■ seborrheic dermatitis ■ 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

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, consult a doctor If pregnant or breast-feeding ■ ask a health professional before use. For external anal itching Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a so...

Storage and handling

■ Storage temperature: not to exceed 30°C (86°F). Protect from freezing. ■ Before using any medication, read all label directions. Keep carton, it contains important information.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Hydrocortisone, USP 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 ■ psoriasis ■ seborrheic dermatitis ■ 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 ■ for external feminine itching if you have a vaginal discharge. Consult a doctor. ■ for the treatment of diaper rash. Consult a doctor.

When using this product

OTC - WHEN USING SECTION

■ avoid contact with the eyes ■ do not begin the use of any other hydrocortisone product unless directed by a doctor ■ for external anal itching: ■ do not use more than directed unless directed by a doctor ■ do not put this product into the rectum by using fingers or any mechanical device or applicator.

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ symptoms last for more than 7 days. ■ the condition gets worse ■ symptoms clear up and occur again in a few days ■ rectal bleeding occurs, consult doctor promptly.

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. 1-800-222-1222

Directions

DOSAGE & ADMINISTRATION SECTION

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, consult a doctor If pregnant or breast-feeding ■ ask a health professional before use.
For external anal itching Adults: when practical, clean the affected area with mild soap and warm water, rinse thoroughly, gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product Children under 12 years of age: consult a doctor

Other information:

STORAGE AND HANDLING SECTION

■ Storage temperature: not to exceed 30°C (86°F). Protect from freezing.
■ Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe vera concentrate, benzyl alcohol, ceteareth 20, cetearyl alchol, cetyl palmitate, glyceryl, isopropyl myristate, isostearyl neopentanoate, methylparaben, peg-40 stearate, purified water. May contain citric acid or sodium citrate solution to adjust pH.

SAFE HANDLING WARNING SECTION

TAMPER EVIDENT DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrocream 1%Hydrocream 1%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1oz1oz

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-317-01Hydrocortisone with aloe28 g in 1 TUBECREAM284
13709-317-01Hydrocortisone with aloe1 in 1 CARTONCREAM14
13709-317-02Hydrocortisone with aloe1 in 1 CARTONCREAM14
13709-317-02Hydrocortisone with aloe56 g in 1 TUBECREAM564

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-317HYDROCORTISONE WITH ALOE (HYDROCORTISONE WITH ALOE ANTI ITCH) CREAM [NEILMED PHARMACEUTICALS INC.]4Current NDC, 4 package rows20240711_032b9f58-5f64-04dd-e063-6294a90a6bb9.zip

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
13709-31713709-317-01, 13709-317-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
Hydrocortisone with aloeHYDROCORTISONE WITH ALOE ANTI ITCHNeilMed Pharmaceuticals Inc.032b9f58-5f64-04dd-e063-6294a90a6bb92024-07-10WarningsExact identifier
ndc (package): 13709-317-01
ndc (package): 13709-317-02
ndc (product): 13709-317
ndc11 (package): 13709031701
ndc11 (package): 13709031702
spl id: 1ce25285-5f43-da63-e063-6394a90ab690
spl set id: 032b9f58-5f64-04dd-e063-6294a90a6bb9

Reported adverse events (FAERS/openFDA)#

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