FDA.reportPublic FDA data

Barmicil plus with Aloe Vera

Manufacturer
OPMX LLC
Effective date
2026-10-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-10-13 04:03:14

Label at a glance#

ProductBarmicil Plus
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 seborrheic dermatitis psoriasis insect bites poison ivy, poison oak, and poison sumac cosmetics jewerly detergents soaps temporarily relieves external anal and genital itching other uses of this product should be only under the advice and supervisor 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. gently dry 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

  • Hydrocortisone 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
  • jewerly
  • detergents
  • soaps
  • temporarily relieves external anal and genital itching
  • other uses of this product should be only under the advice and supervisor 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 symtoms 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

​Keep out of reach of children

OVERDOSAGE 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 itching in adults:
  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
  • gently dry 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)

Inactive 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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free weekdays 9AM to 5 PM PT at 619-600-5236

Made for,

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

Barmicil plus®

con Aloe Vera

1% Hydrocortisone

Crema contra Irritaciones y Alergias de la Piel

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

Maximum Strength Cream

NDC 69729 834 01

Barmicil® plus

with Aloe Vera

1%Hidrocortisona Anti-Itch Cream

Net Wt. 1 oz (28 g)

PDPPDP

PDP interiorPDP interior

Top PDPTop PDP

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		PDP.jpg
QR code linkQR Codeopmx.us/PDP.jpg

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
69729-83469729-834-01

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
CETEARYL ALCOHOL2DMT128M1SIACT
CETEARETH-20YRC528SWUYIACT
LIGHT MINERAL OILN6K5787QVPIACT
CITRIC ACID2968PHW8QPIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-07-24daily-update2026-07-29 05:10:18

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
5763b4de-06f3-7b19-e063-6294a90ad0685763b4de-06f2-7b19-e063-6294a90ad0682026-07-24WarningsExact identifier
spl set id: 5763b4de-06f2-7b19-e063-6294a90ad068

Reported adverse events (FAERS/openFDA)#

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