BARMICIL PLUS- hydrocortisone cream

BARMICIL PLUS by

Drug Labeling and Warnings

BARMICIL PLUS by is a Otc medication manufactured, distributed, or labeled by OPMX LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 HYDROCORTISONE PRODUCT.

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

SPL UNCLASSIFIED SECTION

Made for:

RRX

San Diego, CA

Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

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

INGREDIENTS AND APPEARANCE

BARMICIL PLUS 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
PARAFFIN (UNII: I9O0E3H2ZE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-103-11	28 g in 1 TUBE; Type 0: Not a Combination Product	10/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	10/21/2020

Labeler - OPMX LLC (029918743)