FDA.reportPublic FDA data

Hydrocortisone Cream

Manufacturer
Natureplex, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
16
Source
full-release
Hydrated at
2026-06-01 01:44:08

Label at a glance#

ProductNatureplex Hydrocortisone Hydro
Active ingredientHydrocortisone
Label structure10 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, detergents, cosmetics, jewelry and for external anal and genital itching.

Dosage and administration

For itching associated with minor skin irritations, 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: Consult a doctor For external anal and genital itching: Adults and children 12 years of age and older: when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patti...

Storage and handling

Store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Antipruritic (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, detergents, cosmetics, jewelry
  • and for external anal and genital itching.

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

  • if you have a vaginal discharge. Consult a doctor

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed 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 worsens
  • symptoms persist for more than 7 days or clear up and occurs again within a few days
  • beeding occurs

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away: 800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

For itching associated with minor skin irritations, 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: Consult a doctor

For external anal and genital itching:

Adults and children 12 years of age and older:

  • when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: Consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • Store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Natureplex™

MAXIMUM STRENGTH
Hydrocortisone
Cream

FAST
ITCH & RASH
RELIEF

Net Wt. 1.5 oz. (28g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN16
106258hydrocortisone 10 MG/ML Topical CreamSCD16
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY16
106258hydrocortisone 1 % Topical CreamSY16
106258hydrocortisone 1 GM per 100 GM Topical CreamSY16

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codewww.natureplex.com/product/hydrocortisone-cream/hydro-01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-010-01Natureplex HydrocortisoneHydro28 g in 1 TUBECREAM2816
67234-010-02Natureplex HydrocortisoneHydro42.5 g in 1 TUBECREAM42.516
67234-010-02Natureplex HydrocortisoneHydro1 in 1 CARTONCREAM116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67234-010-01GM - Gram67234-010c4e34dac-eadb-4f14-8d58-68c39ddb36bd12024-04-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJ12
HydrocortisoneACTIVE MOIETYWI4X0X7BPJ12
alcoholINACTIVE INGREDIENT3K9958V90M12
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0X12
carbomer homopolymer type CINACTIVE INGREDIENT4Q93RCW27E12
cetyl alcoholINACTIVE INGREDIENT936JST6JCN12
DMDM HydantoinINACTIVE INGREDIENTBYR0546TOW12
edetate trisodiumINACTIVE INGREDIENT420IP921MB12
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE412
methylparabenINACTIVE INGREDIENTA2I8C7HI9T12
mineral oilINACTIVE INGREDIENTT5L8T28FGP12
polysorbate 20INACTIVE INGREDIENT7T1F30V5YH12
propylparabenINACTIVE INGREDIENTZ8IX2SC1OH12
stearic acidINACTIVE INGREDIENT4ELV7Z65AP12
trolamineINACTIVE INGREDIENT9O3K93S3TK12
waterINACTIVE INGREDIENT059QF0KO0R12

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67234-01067234-010-01, 67234-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
HydrocortisoneWI4X0X7BPJACTIB
ALOE VERA LEAF JUICERUE8E6T4NBIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
cetyl alcohol936JST6JCNIACT
DMDM HydantoinBYR0546TOWIACT
glyceryl monostearate230OU9XXE4IACT
ISOPROPYL ALCOHOLND2M416302IACT
methylparabenA2I8C7HI9TIACT
mineral oilT5L8T28FGPIACT
polysorbate 207T1F30V5YHIACT
propylparabenZ8IX2SC1OHIACT
water059QF0KO0RIACT
stearic acid4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
edetate trisodium420IP921MBIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 2 · 66 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
33 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
33 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
33 equally ranked IID candidates
edetate trisodiumEDETATE TRISODIUM420IP921MBCREAM / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
glyceryl monostearateGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
33 equally ranked IID candidates
DMDM HydantoinDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
33 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
33 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
carbomer homopolymer type CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
33 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
33 equally ranked IID candidates
edetate trisodiumEDETATE TRISODIUM420IP921MBCREAM / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
33 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
33 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
33 equally ranked IID candidates
edetate trisodiumEDETATE TRISODIUM420IP921MBCREAM / TOPICALNAExact identifier — unii+route+dosage form
3 equally ranked IID candidates
carbomer homopolymer type CCARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27ECREAM / TOPICAL103 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
33 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
methylparabenMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
33 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
33 equally ranked IID candidates
trolamineTROLAMINE9O3K93S3TKCREAM / TOPICAL1 %w/wExact identifier — unii+route+dosage form
3 equally ranked IID candidates
stearic acidSTEARIC ACID4ELV7Z65APCREAM / TOPICAL190 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
33 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
cetyl alcoholCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
33 equally ranked IID candidates
DMDM HydantoinDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
33 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
DMDM HydantoinDMDM HYDANTOINBYR0546TOWLOTION / TOPICAL3 mgExact identifier — unii+route
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
33 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
33 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
33 equally ranked IID candidates
alcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
33 equally ranked IID candidates
alcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
33 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
propylparabenPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
33 equally ranked IID candidates
mineral oilMINERAL OILT5L8T28FGPCREAM / TOPICAL2772 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
33 equally ranked IID candidates
alcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
33 equally ranked IID candidates
polysorbate 20POLYSORBATE 207T1F30V5YHCREAM / TOPICAL108 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
alcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
33 equally ranked IID candidates

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
Natureplex Hydrocortisone HydroHYDROCORTISONENatureplex, LLC2fc6a148-34bb-4289-8588-32c1bb011b982026-02-13WarningsExact identifier
ndc (package): 67234-010-02
ndc (package): 67234-010-01
ndc (product): 67234-010
ndc11 (package): 67234001002
ndc11 (package): 67234001001
spl id: c04d26f2-8870-4d41-91a9-519c349b517a
spl set id: 2fc6a148-34bb-4289-8588-32c1bb011b98

Reported adverse events (FAERS/openFDA)#

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