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| Product NDC Code | 42961-237 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Xpect hydrocortisone |
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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 | part348 | ||||||
| Labeler Name | Cintas Corporation | ||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients (in each gram) 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 for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily children under 12 years of age: for external anal itching, consult a doctor children under 2: do not use, consult a doctor adults for external anal itching 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 application of this product
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients cetyl alcohol*, citric acid*, diazolidinyl urea*, edetate disodium*, emulsifying wax*, ethanol*, glycerin*, glyceryl monostearate*, methylparaben, mineral oil, paraffin*, petrolatum*, polyethylene glycol*, propylene glycol*, propylparaben, stearic acid*, trolamine*, water, white wax* *may contain ingredient
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, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes other uses of 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 cream
Spl product data elements
Usually a list of ingredients in a drug product.Xpect Hydrocortisone Hydrocortisone HYDROCORTISONE HYDROCORTISONE METHYLPARABEN MINERAL OIL PARAFFIN PETROLATUM PROPYLPARABEN WATER ALCOHOL CETOSTEARYL ALCOHOL POLYSORBATE 60 PEG-150 DISTEARATE STEARETH-20
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 42961-235-02 HYDROCORTISONE Active Ingredient: Hydrocortisone 1% Anti-itch cream For temporary relief of itching associated with minor skin irritations, inflammation, or rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, and otehr skin irritations. Distributed by: Cintas • Mason, OH 45040 • www.cintas.com Xpect® First aid NET WT PER PKT 1/32 OZ (0.9g) 10 Packets per Box 10_CT_BOX
Principal Display Panel 42961-235-03 HYDROCORTISONE Hydrocortisone 1% Anti-itch cream For temporary relief of itching associated with minor skin irritations, inflammation, or rashes. Xpect® First aid Distributed by: Cintas • Mason, OH 45040 • www.cintas.com NET WT PER PKT 1/32 OZ (0.9g) 20 Packets per Box 20_CT_BOX
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 in eyes for feminine itching
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information clean the affected area store at room temperature (do not freeze) do not use any opened or torn packets
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-877-973-2811 M-F 8 am - 5 pm
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 use and ask a doctor if condition worsens or lasts more than 7 days, or clears up and ocurs again within a few days you begin use of any other Hydrocortisone product unless you have consulted a doctor if bleeding occurs
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. Do not use for the treatment of diaper rash in eyes for feminine itching Stop use and ask a doctor if condition worsens or lasts more than 7 days, or clears up and ocurs again within a few days you begin use of any other Hydrocortisone product unless you have consulted a doctor if bleeding occurs 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