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Cortizone 10 itch relief massaging rollerball - Medication Information

Product NDC Code 41167-0338
Drug Name

Cortizone 10 itch relief massaging rollerball

Type Brand
Pharm Class Corticosteroid Hormone Receptor Agonists [MoA],
Corticosteroid [EPC]
Active Ingredients
Hydrocortisone 1 g/100g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 106258,
206352
Application Number M017
Labeler Name Chattem, Inc.
Packages
Package NDC Code Description
41167-0338-0 1 bottle, with applicator in 1 carton (41167-0338-0) / 42 g in 1 bottle, with applicator
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active i ngredient

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, ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
In active ingredients water, alcohol denat. (15%), dimethicone, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, glycerin, ethylhexylglycerin, aloe barbadensis leaf juice, hydroxyacetophenone, glyceryl stearate, C30-45 alkyl cetearyl dimethicone crosspolymer, isohexadecane, acrylates/C10-30 alkyl acrylate crosspolymer, dicetyl phosphate, aminomethyl propanol, steareth-2, steareth-21, polysorbate 60, disodium EDTA, citric acid

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.
Use s ■ temporarily relieves 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 Hydrocortisone 1%...........................................................................................................................................Anti-itch

Spl product data elements

Usually a list of ingredients in a drug product.
Cortizone 10 Itch Relief Massaging Rollerball Hydrocortisone HYDROCORTISONE HYDROCORTISONE WATER ALCOHOL DIMETHICONE CAPRYLYL TRISILOXANE CETOSTEARYL ALCOHOL CETETH-20 PHOSPHATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) GLYCERIN ETHYLHEXYLGLYCERIN ALOE VERA LEAF HYDROXYACETOPHENONE GLYCERYL MONOSTEARATE C30-45 ALKYL CETEARYL DIMETHICONE CROSSPOLYMER ISOHEXADECANE DIHEXADECYL PHOSPHATE AMINOMETHYLPROPANOL STEARETH-2 STEARETH-21 POLYSORBATE 60 EDETATE DISODIUM ANHYDROUS CITRIC ACID MONOHYDRATE CARBOMER COPOLYMER TYPE A

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 Itch Relief Massaging Rollerball 1.5 FL OZ (44.3 mL) PRINCIPAL DISPLAY PANEL Cortizone 10 Itch Relief Massaging Rollerball 1.5 FL OZ (44.3 mL)

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.
Cortizone 10 Itch Relief Massaging Rollerball 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 ■ 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 ■ 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. ■ if you are allergic to any ingredient in this product When using this product ■ avoid contact with the 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, 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