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| Product NDC Code | 0394-0859 | ||||
|---|---|---|---|---|---|
| Drug Name | Hydrocortisone |
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| Type | Generic | ||||
| Pharm Class | Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| RxCUI drug identifier | 103403 | ||||
| Application Number | part348 | ||||
| Labeler Name | Mericon Industries | ||||
| 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 of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: do not use, consult a doctor For External Anal Itching Users adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product children under 12 years of age: consult a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients stearic acid, propylene glycol, lanolin alcohol in mineral oil, isopropyl in myristate, cetyl alcohol, mono- and di-glycerides, polysorbate 80, sorbitan monooleate, a scent and purified water preserved with methylparaben and propylparaben.
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 associated with minor skin irritations, inflammation and rashes due to: eczema seborrheic dermatitis psoriasis insect bites poison ivy, oak, sumac soaps detergents cosmetics jewelry external genital and anal 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.Hydrocortisone Hydrocortisone Hydrocortisone Hydrocortisone stearic acid propylene glycol lanolin alcohols mineral oil MYRISTIC ACID cetyl alcohol polysorbate 80 sorbitan monooleate water methylparaben propylparaben
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.PRINCIPAL DISPLAY PANEL - 114 g Bottle Label 0394-0859-32 Mericon Industries, Inc. Hydrocortisone 1% Lotion Anti-Itch Poison Ivy Poison Oak Poison Sumac Hives • Rashes Net Wt. 4 oz. (114g) PRINCIPAL DISPLAY PANEL - 114 g Bottle Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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 this product and ask a doctor if you have a vaginal discharge before treating diaper rash before using on children under 2 years of age
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 this and all drugs out of the reach of children
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 using this product and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days before you begin using any other hydrocortisone product
Storage and handling
Information about safe storage and handling of the drug product.Other Information store at 55 to 76F
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 avoid contact with the eyes Stop using this product and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days before you begin using any other hydrocortisone product Do not use this product and ask a doctor if you have a vaginal discharge before treating diaper rash before using on children under 2 years of age For external anal itching users do not exceed the recommended daily dosage unless directed by a doctor in case of bleeding, consult a doctor promptly do not put this product into the rectum by using fingers or any mechanical device or applicator Keep this and all drugs out of the reach of children
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