BARMICIL PLUS by OPMX LLC BARMICIL PLUS

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]

BARMICIL PLUS- hydrocortisone cream 
OPMX LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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BARMICIL PLUS

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.

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

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	05/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	10/21/2020	05/30/2022

Labeler - OPMX LLC (029918743)

Revised: 3/2022

Document Id: d9f9126a-1303-2865-e053-2a95a90a2166

34390-5

Set id: fb5f4743-61e8-46c8-8561-38e17aeaa4d5

Version: 5

Effective Time: 20220311