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| Product NDC Code | 41167-0343 | ||||
|---|---|---|---|---|---|
| Drug Name | Cortizone 10 fast acting itch relief cooling |
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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 | SPRAY | ||||
| RxCUI drug identifier | 212567, 317564 |
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| Application Number | M017 | ||||
| Labeler Name | Chattem, Inc. | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients 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.D irections ■ adults and children 2 years of age and older : apply to affected area. Do not use more than 3 to 4 times daily. ■ children under 2 years of age: do not use, ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients alcohol denat., aloe barbadensis leaf juice, avena sativa (oat) kernel extract, citric acid, ethoxydiglycol, glycerin, hydroxypropyl cellulose, isobutane, menthyl lactate, methyl gluceth-20, PEG-8, water
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 ■ psoriasis ■ poison ivy, oak, sumac ■ insect bites ■ detergents ■ jewelry ■ cosmetics ■ soaps ■ seborrheic dermatitis ■ 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.Cortizone 10 Fast Acting Itch Relief Cooling Hydrocortisone HYDROCORTISONE HYDROCORTISONE ALCOHOL ALOE VERA LEAF OAT CITRIC ACID MONOHYDRATE DIETHYLENE GLYCOL MONOETHYL ETHER GLYCERIN HYDROXYPROPYL CELLULOSE, UNSPECIFIED ISOBUTANE MENTHYL LACTATE, (-)- METHYL GLUCETH-20 POLYETHYLENE GLYCOL 400 WATER
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 Cortizone 10 FAST ACTING ITCH RELIEF COOLING SPRAY SOOTHING ALOE 1% Hydrocortisone Anti-Itch Spray Net wt 2.7 oz (76 g) Cortizone 10 FAST ACTING ITCH RELIEF COOLING SPRAY SOOTHING ALOE 1% Hydrocortisone Anti-Itch Spray Net wt 2.7 oz (76 g)
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
Other information Store between 20° to 25°C (68° to 77°F)
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 us e ■ for the treatment of diaper rash. Consult a doctor. ■ if you are allergic to any ingredient in this product.
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 use and ask a doctor if ■ condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days, do not use this or any other hydrocortisone product unless you have asked a doctor.
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 ■ avoid contact with the eyes ■ contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. ■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. ■ do not use more than directed unless told to do so by a doctor
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 . Flam mable. Keep away from fire or flame. Do not us e ■ for the treatment of diaper rash. Consult a doctor. ■ if you are allergic to any ingredient in this product. When using this product ■ avoid contact with the eyes ■ contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120° F. ■ use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. ■ do not use more than directed unless told to do so by a doctor Stop use and ask a doctor if ■ condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days, do not use this or any other hydrocortisone product unless you have asked a doctor. 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