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| Product NDC Code | 69968-0888 | ||||
|---|---|---|---|---|---|
| Drug Name | Aveeno 1% hydrocortisone anti-itch cream |
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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 | CREAM | ||||
| Application Number | M017 | ||||
| Labeler Name | Kenvue Brands LLC | ||||
| 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 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 Palmitate, Ceteareth-20, Avena Sativa (Oat) Kernel Flour, Potassium Lactate, Ethylhexyl Palmitate, Cetyl Palmitate, Phenoxyethanol, Caprylyl Glycol, PEG-80 Sorbitan Laurate, 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 1% Hydrocortisone Anti-Itch Cream Hydrocortisone WATER GLYCERIN ISOPROPYL PALMITATE POLYOXYL 20 CETOSTEARYL ETHER OATMEAL POTASSIUM LACTATE ETHYLHEXYL PALMITATE CETYL PALMITATE PHENOXYETHANOL CAPRYLYL GLYCOL PEG-80 SORBITAN LAURATE CITRIC ACID MONOHYDRATE .ALPHA.-TOCOPHEROL ACETATE ALOE VERA LEAF HYDROCORTISONE HYDROCORTISONE OAT OAT KERNEL OIL SODIUM HYDROXIDE CETOSTEARYL ALCOHOL
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 in a Carton Label Aveeno ® 1% Hydrocortisone ANTI-ITCH CREAM Effectively relieves itch from: Eczema ● Psoriasis Poison Ivy ● Oak ● Sumac Insect Bites ● Detergents ● Soaps Maximum Strength Formula With Triple Oat, Aloe, & Vitamin E DERMATOLOGIST RECOMMENDED BRAND TRIPLE OAT net wt. 1 oz (28 g) Aveeno-1
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
Distributed by: Kenvue Brands LLC Summit, NJ 07901
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 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 persist 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 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. 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 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 persist 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