Barmicil Plus

Barmicil Plus
SPL v10
SPL
SPL Set ID fb5f4743-61e8-46c8-8561-38e17aeaa4d5
Route
TOPICAL
Published
Effective Date 2020-10-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Aloe Vera Leaf Cetostearyl Alcohol Glyceryl Stearate Se Methylisothiazolinone Propylene Glycol Water Stearic Acid Trolamine Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-10-21

Description

HYDROCORTISONE USP 1%

Purpose

ANTI-ITCH


Medication Information

Purpose

ANTI-ITCH

Description

HYDROCORTISONE USP 1%

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

Section 50565-1

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

Section 51945-4

Barmicil plus

with Aloe Vera

1% Hydrocortisone Anti-Itch Cream

Net Wt. 1 oz (28g)

Inflammation & Redness

Skin Irritation & Rashes

Insect Bites, Poison Ivy

Eczema & Psoriasis

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.

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)
Active Ingredients

HYDROCORTISONE USP 1%

Inactive Ingredients

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


Structured Label Content

Uses (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

Section 50565-1 (50565-1)

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

Section 51945-4 (51945-4)

Barmicil plus

with Aloe Vera

1% Hydrocortisone Anti-Itch Cream

Net Wt. 1 oz (28g)

Inflammation & Redness

Skin Irritation & Rashes

Insect Bites, Poison Ivy

Eczema & Psoriasis

Purpose (PURPOSE)

ANTI-ITCH

Warnings (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.

Directions (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 (OTHER INFORMATION)
  • STORE AT 20°C TO 25°C (68°F TO 77°F)
Active Ingredients (ACTIVE INGREDIENTS)

HYDROCORTISONE USP 1%

Inactive Ingredients (INACTIVE INGREDIENTS)

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


Advanced Ingredient Data


Raw Label Data

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