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Theraplex aim anti-itch moisturizing - Medication Information

Product NDC Code 82280-478
Drug Name

Theraplex aim anti-itch moisturizing

Type Brand
Pharm Class Corticosteroid Hormone Receptor Agonists [MoA],
Corticosteroid [EPC]
Active Ingredients
Hydrocortisone 10 mg/g
Route TOPICAL
Dosage Form CREAM
RxCUI drug identifier 106258
Application Number M017
Labeler Name THERAPLEX, LLC
Packages
Package NDC Code Description
82280-478-02 56.7 g in 1 jar (82280-478-02)
82280-478-03 85 g in 1 jar (82280-478-03)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Hydrocortisone 1% Purpose Anti-Itch

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.
Inactive Ingredients Petrolatum (special fraction), cyclomethicone, coconut oil, microcrystalline wax, ferulic acid, colloidal oatmeal

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 itching associated with minor skin irritations, inflammation, and rashes due to: eczema soaps detergents cosmetics seborrheic dermatitis psoriasis. 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.
THERAPLEX AIM Anti-Itch Moisturizing HYDROCORTISONE PETROLATUM CYCLOMETHICONE COCONUT OIL MICROCRYSTALLINE WAX FERULIC ACID OATMEAL HYDROCORTISONE HYDROCORTISONE

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.
Package Labeling 2oz: Label0 Package Labeling 3oz: 3oz

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 at 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 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.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions? Toll-free number 888-437-2753 For more information on Eczema and Theraplex, visit us on our website at www.theraplex.com

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 more than 7 days, or clear up and occur again within a few days. 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.

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. Stop use and ask a doctor if condition worsens, symptoms persist more than 7 days, or clear up and occur again within a few days. 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