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| Product NDC Code | 69729-301 | ||||
|---|---|---|---|---|---|
| Drug Name | Barmicil anti-itch |
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| Type | Brand | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| RxCUI drug identifier | 106258 | ||||
| Application Number | M017 | ||||
| Labeler Name | OPMX LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Hydrocortisone 1 %
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredient aloe barbadensis (aloe vera) leaf juice, cetearyl alcohol, glycerin, light mineral oil, potassium sorbate, purified water, sodium benzoate, sodium cetearyl sulfate, sodium lauryl sulfate, white petrolatum, white wax
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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 product should be only under the advice and supervision of a doctor
Purpose
Information about the drug product’s indications for use.Purpose Anti-Itch
Spl product data elements
Usually a list of ingredients in a drug product.Barmicil Anti-itch HYDROCORTISONE PETROLATUM CETOSTEARYL ALCOHOL GLYCERIN SODIUM BENZOATE ALOE VERA LEAF SODIUM LAURYL SULFATE LIGHT MINERAL OIL POTASSIUM SORBATE WATER WHITE WAX SODIUM CETOSTEARYL SULFATE HYDROCORTISONE HYDROCORTISONE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Content of labeling Hydrocortisone Cream 1% with Aloe Vera Principal Display Panel
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use for the treatment of diaper rash. Ask a doctor. for external genital itching if you have a vaginal discharge. Ask a doctor. for external anal itching if rectal bleeding occurs. Consult a doctor promptly.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop us and ask 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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Storage and handling
Information about safe storage and handling of the drug product.Other information store at 20 °C to 25 °C (68 °F to 77 °F)
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only 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 Do not use for the treatment of diaper rash. Ask a doctor. for external genital itching if you have a vaginal discharge. Ask a doctor. for external anal itching if rectal bleeding occurs. Consult a doctor promptly. Stop us and ask 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 a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API