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  5. Label Information: Barmicil Plus

FDA Label for Barmicil Plus

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DIRECTIONS
    7. OTHER INFORMATION
    8. INACTIVE INGREDIENTS
    9. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Barmicil Plus Product Label

The following document was submitted to the FDA by the labeler of this product Opmx Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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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