Active Ingredients
HYDROCORTISONE USP 1%
Barmicil Plus Cream
FDA Label NDC 69729-103
13 label sections · Submitted to the FDA by Opmx Llc · 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, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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
Other
Made for:
RRX
San Diego, CA
Exclusively distributed by:
OPMX
Chula Vista, CA 91910
Phone: 619-600-5632
Package Label.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
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