FDA.reportPublic FDA data

BARMICIL PLUS

Manufacturer
OPMX LLC
Effective date
2026-03-24
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
full-release
Hydrated at
2026-06-01 01:51:31

Label at a glance#

ProductBARMICIL PLUS
Active ingredientHYDROCORTISONE
Label structure9 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 PRODUC 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 ITCHING IN ADULTS: WHEN PRACTICAL, CLEANSE THE AFFECTED AREA WITH MILD SOAP AND 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 APPLYING. FOR EXTE...

Storage and handling

STORE AT 20°C TO 25°C (68°F TO 77°F)

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

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
  •     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 PRODUC 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 DISCGARGE. ASK A DOCTOR.
  • FOR EXTERNAL ANAL ITCHING IF RECTAL BLEEDING OCCURS. CONSULT A DOCTOR PROMPTLY.

When using this product

OTC - WHEN USING SECTION

  • DO NOT GET INTO THE EYES
  • FOR EXTERNAL ANAL ITCHING, 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed get medical help or contact 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 ITCHING IN ADULTS:
  • WHEN PRACTICAL, CLEANSE THE AFFECTED AREA WITH MILD SOAP AND 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 APPLYING.
  • FOR EXTERNAL ANAL ITCHING IN CHILDREN UNDER 12 YEARS: ASK A DOCTOR.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

  • STORE AT 20°C TO 25°C (68°F TO 77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

ALOE VERA LEAF EXTRACT, CETOSTEARYL ALCOHOL, GLYCERYL MONOSTEARATE SE, METHYLISOTHIAZOLINONE, PROPYLENE GLYCOL, PURIFIED WATER, STEARIC ACID, TRIETHANOLAMINE, WHITE SOFT PARAFFIN

SPL UNCLASSIFIED SECTION

Made for:

RRX

San Diego, CA

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 69729-103-11

Barmicil® plus

with Aloe Vera

1% Hydrocortisone Anti-Itch Cream

Net Wt. 1 oz (28g)

Maximum Strength Cream

  • Inflammation & Redness
  • Skin Irritation & Rashes
  • Insect Bites, Poison Ivy
  • Eczema & Psoriasis
  • Inflamación y Ardor
  • Irritación y Alergia
  • Piquetes de Insectos y Hiedra venenosa
  • Eczema y Psoriasis

BOXBOXTUBETUBE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN11
106258hydrocortisone 10 MG/ML Topical CreamSCD11
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY11
106258hydrocortisone 1 % Topical CreamSY11
106258hydrocortisone 1 GM per 100 GM Topical CreamSY11

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
BarcodeEAN-130856828008731GTIN-13: 0856828008731
EAN-13: 0856828008731
GTIN-12: 856828008731
UPC-A: 856828008731
GTIN storage (14 digits): 00856828008731		BARMICIL PLUS NEW LABEL.jpg
QR code linkQR Codeopmx.us/BARMICIL PLUS NEW LABEL.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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-103-112022-03-24C16284748780-1d6a99b39-cfa0-a426-e053-dadaa90af4c2BARMICIL PLUS
69729-103-112022-01-28C16284748780-1d6a99b39-cfa0-a426-e053-dadaa90af4c2BARMICIL PLUS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-103-11BARMICIL PLUS28 g in 1 TUBECREAM2811

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
69729-10369729-103-11

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
ALOE VERA LEAFZY81Z83H0XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
PARAFFINI9O0E3H2ZEIACT
HYDROCORTISONEWI4X0X7BPJACTIB

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
BARMICIL PLUSHYDROCORTISONEOPMX LLCfb5f4743-61e8-46c8-8561-38e17aeaa4d52026-03-24WarningsExact identifier
ndc (package): 69729-103-11
ndc (product): 69729-103
ndc11 (package): 69729010311
spl id: 4dc90c9e-1e77-3b65-e063-6394a90a2cbd
spl set id: fb5f4743-61e8-46c8-8561-38e17aeaa4d5

Reported adverse events (FAERS/openFDA)#

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