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Afassco 1% hydrocortisone - Medication Information

Product NDC Code 51532-4608
Drug Name

Afassco 1% hydrocortisone

Type Brand
Pharm Class Corticosteroid Hormone Receptor Agonists [MoA],
Corticosteroid [EPC]
Active Ingredients
Hydrocortisone .01 g/g
Route TOPICAL
Dosage Form OINTMENT
Application Number part348
Labeler Name Afassco Inc.
Packages
Package NDC Code Description
51532-4608-1 25 pouch in 1 box (51532-4608-1) / 1 g in 1 pouch
51532-4608-2 6 pouch in 1 box (51532-4608-2) / 1 g in 1 pouch
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients (In Each Gram) 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 • For 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, consult a doctor • Adults for external anal itching when practical, cleanse the area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad • Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product • Children under 12 years of age; for external itching, consult a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water, Cetearyl Alcohol, Glycerin, Ceteareth-20, Isopropyl Myristate, EDTA-2NA, Phenoxyethanol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice

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 : for the temporary temporarily relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis scrapes for external genital, feminine, and anal itching 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 Anti-itch

Spl product data elements

Usually a list of ingredients in a drug product.
AFASSCO 1% Hydrocortisone HYDROCORTISONE HYDROCORTISONE HYDROCORTISONE WATER CETOSTEARYL ALCOHOL GLYCERIN POLYOXYL 20 CETOSTEARYL ETHER ISOPROPYL MYRISTATE EDETATE DISODIUM PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE, D- ALOE VERA LEAF

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 Afassco¦ ¦ ® The First Choice in First Aid MAXIMUM STRENGTH HYDROCORTISONE PLUS MOISTURIZING ALOE 1% ANTI-ITCH ANALGESIC • FOR THE TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS No. 608 25 ct. Afassco¦ ¦ ® The First Choice in First Aid REMOVE TOP FOR EASY ACCESS Compare To Hydrocortisone MAXIMUM STRENGTH HYDROCORTISONE 1% ANTI-ITCH ANALGESIC • FOR THE TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS No. 608 25 ct. Afassco¦ ¦ ® The First Choice in First Aid MAXIMUM STRENGTH HYDROCORTISONE 1% Crema de Fydrocortisona instructiones: Para Adultos y ninos 2 anos y mas viejo. Los ninos bajo 2 anos, consultan un medico para picar anal externo. Limpia el areaa afectada con jabon y aclarado aplique el producto. 1% ANTI-ITCH ANALGESIC • FOR THE TEMPORARY RELIEF OF MINOR SKIN IRRITATIONS No. 608 25 ct. Afassco¦ ¦ ® The First Choice in First Aid Manufactured for Afassco, Inc. Minden, NV 89423 6 70254 60812 5 ↓25 ct. Box↓ ↓6 ct. Box↓ ↓Unit Dose Package Label↓ Afassco¦ ¦ ® The First Choice in First Aid 1% Hydrocortisone Cream Manufactured for Afassco Minden, NV 89423 1gm (1/32 oz) Made in China res Hydrocrtson 380 6ct Hydrocrtson 608 25ct Hydrocort pouch

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 Hydrocorticone Cream 1%

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.
Consult a doctor: before use if you have a vaginal discharge (for external feminine itching) for external itching, do not exceed the recommended daily dosage or if bleeding occurs if condition worsens or if symptoms persist for more than 7 days or clear up and occur again in a few days 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: with any other Hydrocortisone product unless you have consulted 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 contact a Poison Control center right away.

Other safety information

Information about safe use and handling of the product that may not have been specified in another field.
Other Information: Store at controlled room temperature 15° to 30° C (59° to 86° F) Tamper evident. Do not use if packet is torn, cut, or opened. Avoid excessive heat and humidity

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 contacty with eyes do not put this produce into rectum by using fingers or any mechanical device or applicator

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

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