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Cortizone 10 intensive healing for eczema - Medication Information

Product NDC Code 41167-0331
Drug Name

Cortizone 10 intensive healing for eczema

Type Brand
Pharm Class Corticosteroid Hormone Receptor Agonists [MoA],
Corticosteroid [EPC]
Active Ingredients
Hydrocortisone 10 mg/g
Route TOPICAL
Dosage Form LOTION
RxCUI drug identifier 103403,
1039279
Application Number M017
Labeler Name Chattem, Inc.
Packages
Package NDC Code Description
41167-0331-0 1 tube in 1 carton (41167-0331-0) / 99 g in 1 tube
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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 : ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients aloe barbadensis leaf juice, avena sativa (oat) kernel extract, bisabolol, boswellia serata gum, butyrospermum parkii (shea) butter extract, cetyl alcohol, dextrin, dimethicone, dipropylene glycol, disodium EDTA, glycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, magnesium ascorbyl phosphate, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 60, propylparaben, retinyl palmitate, sodium citrate, tocopheryl acetate, water, singiber officinale (ginger) root extract (283-035) *Clinically proven to moisturize for 24 hours **Refers to the ingredient hydrocortisone †Contains 7 healing moisturizers and vitamins A, C & E

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 temporarily relieves the itching and discomfort associated with minor skin irritations, rashes, and inflammation, and due to eczema other uses of this product should only be 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 Intensive Healing for Eczema Hydrocortisone HYDROCORTISONE HYDROCORTISONE ALOE VERA LEAF CETYL ALCOHOL DIMETHICONE DIPROPYLENE GLYCOL EDETATE DISODIUM GLYCERIN GLYCERYL MONOSTEARATE MALTODEXTRIN METHYLPARABEN PETROLATUM PHENOXYETHANOL POLYSORBATE 60 PROPYLPARABEN VITAMIN A PALMITATE SODIUM CITRATE .ALPHA.-TOCOPHEROL ACETATE, D- 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 NEW! Fast, Lasting Itch Relief MAXIMUM STRENGTH Cortizone-10 ® INTENSIVE HEALING LOTION † ECZEMA And Itchy, Dry Skin Dermatologist Recommended 7 intensive moisturizers Clinical strength* With Restora TM Botanical & Vitamin Complex 1% Hydrocortisone Anti-Itch Lotion DOCTORS #1 ITCH MEDICINE RECOMMEND Net wt 3.5 oz ( 99 g) Principal Display Panel NEW! Fast, Lasting Itch Relief MAXIMUM STRENGTH Cortizone-10® INTENSIVE HEALING LOTION† ECZEMA And Itchy, Dry Skin Dermatologist Recommended  7 intensive moisturizers  Clinical strength* With Restora TM Botanical & Vitamin Complex 1% Hydrocortisone Anti-Itch Lotion DOCTORS #1 ITCH MEDICINE RECOMMEND Net wt 3.5 oz (99g)

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.
Other information contents filled by weight, not volume

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. Consult a doctor.

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, and do not begin use of 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 eyes 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 Do not use for the treatment of diaper rash. Consult a doctor. When using this product avoid contact with eyes 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, and do not begin use of 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