Barmicil Plus Cream
FDA Label NDC 69729-103

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Barmicil Plus (NDC 69729-103). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

HYDROCORTISONE USP 1%

Purpose

ANTI-ITCH

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

Warnings

For external use only.

DO NOT USE

  • 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

    • 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

      • 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 HYDROQUINONE PRODUCT.

Otc - Keep Out Of Reach Of Children

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

Directions

  • 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

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

Inactive Ingredients

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

Package Label.Principal Display Panel

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