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Aveeno hydrocortisone anti-itch - Medication Information

Product NDC Code 69968-0511
Drug Name

Aveeno hydrocortisone anti-itch

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 part348
Labeler Name Johnson & Johnson Consumer Inc.
Packages
Package NDC Code Description
69968-0511-1 1 tube in 1 carton (69968-0511-1) / 28 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, do not use; ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients Water, Cetearyl Alcohol, Glycerin, Isopropyl Myristate, Cetereath-20, Cyclopentasiloxane, Avena Sativa (Oat) Kernel flour, Cetyl Palmitate, Isostearyl Neopentanoate, Benzyl Alcohol, Dimethicone/Vinyltrimethylsiloxysilicate Crosspolymer, Potassium Lactate, PEG-40 Stearate, Methylparaben, Citric Acid, Tocopheryl Acetate, Aloe Barbadensis Leaf Extract, Avena Sativa (Oat) Kernel Oil, Avena Sativa (Oat) Kernel Extract, Sodium Hydroxide

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 For the temporary relief of itching associated with minor skin irritations and rashes due to: eczema insect bites poison ivy, oak or sumac soaps and detergents cosmetics jewelry seborrheic dermatitis psoriasis Other uses of this product should be only under the advice and supervision of 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.
Aveeno Hydrocortisone ANTI-ITCH Hydrocortisone WATER CETOSTEARYL ALCOHOL GLYCERIN ISOPROPYL MYRISTATE POLYOXYL 20 CETOSTEARYL ETHER CYCLOMETHICONE 5 OATMEAL CETYL PALMITATE ISOSTEARYL NEOPENTANOATE BENZYL ALCOHOL POTASSIUM LACTATE METHYLPARABEN CITRIC ACID MONOHYDRATE .ALPHA.-TOCOPHEROL ACETATE OAT KERNEL OIL OAT ALOE VERA LEAF SODIUM HYDROXIDE PEG-40 STEARATE 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.
PRINCIPAL DISPLAY PANEL - 28 g Tube Carton Aveeno® 1% Hydrocortisone ANTI-ITCH CREAM Effectively relieves itch from: Eczema ● Psoriasis Poison Ivy ● Oak ● Sumac Insect Bites ● Detergents ● Soaps Maximum Strength Formula Specially formulated for longer-lasting relief With Triple Oat, Aloe, & Vitamin E DERMATOLOGIST RECOMMENDED BRAND TRIPLE OAT net wt. 1 oz (28 g) Aveeno

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 Sunburn Alert This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards. Distributed by: JOHNSON & JOHNSON CONSUMER INC. Skillman, NJ 08558

Ask doctor

Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.
Ask a doctor before use if you are using any other hydrocortisone product

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 in or near the eyes for diaper rash; ask 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? 866-428-3366; Outside US, dial collect 215-273-8755 www.aveeno.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 or if symptoms persists for more than 7 days symptoms last more than 7 days or clear up and occur again within a few days

Storage and handling

Information about safe storage and handling of the drug product.
Other information Protect from Excessive Heat (40°c/104°F)

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 in or near the eyes for diaper rash; ask a doctor Ask a doctor before use if you are using any other hydrocortisone product Stop use and ask a doctor if condition worsens or if symptoms persists for more than 7 days symptoms last more than 7 days or clear up and occur again within a few days 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