NDC 81238-4608 Maximum Strength Hydrocortisone Plus Moisturizing Aloe

Hydrocortisone

NDC Product Code 81238-4608

NDC CODE: 81238-4608

Proprietary Name: Maximum Strength Hydrocortisone Plus Moisturizing Aloe What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Hydrocortisone What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Hydrocortisone reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

NDC Code Structure

  • 81238 - Western First Aid Safety Dba Aramark

NDC 81238-4608-1

Package Description: 25 POUCH in 1 BOX > 1 g in 1 POUCH

NDC 81238-4608-2

Package Description: 6 POUCH in 1 BOX > 1 g in 1 POUCH

NDC Product Information

Maximum Strength Hydrocortisone Plus Moisturizing Aloe with NDC 81238-4608 is a a human over the counter drug product labeled by Western First Aid Safety Dba Aramark. The generic name of Maximum Strength Hydrocortisone Plus Moisturizing Aloe is hydrocortisone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Western First Aid Safety Dba Aramark

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Maximum Strength Hydrocortisone Plus Moisturizing Aloe Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HYDROCORTISONE 10 mg/g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Western First Aid Safety Dba Aramark
Labeler Code: 81238
FDA Application Number: part348 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-16-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Information for Patients

Hydrocortisone Topical

Hydrocortisone Topical is pronounced as (hye droe kor' ti sone)

Why is hydrocortisone topical medication prescribed?
Hydrocortisone topical is used to treat redness, swelling, itching, and discomfort of various skin conditions. Hydrocortisone is in a class of medications called corticos...
[Read More]
Steroids

Steroids is

...
[Read More]

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Maximum Strength Hydrocortisone Plus Moisturizing Aloe Product Label Images

Maximum Strength Hydrocortisone Plus Moisturizing Aloe Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Drug Facts

Active Ingredients:Hydrocortisone Cream 1%Active Ingredients (In Each Gram)

Otc - Purpose

PurposeHydrcortisone 1% ...... Anti Itch

Indications & Usage

Uses: • for the temporary relief of itching associated with minor skin irritations,inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poisonsumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasisscrapes • for external genital, feminine, and anal itching • other uses of this productshould be only under the advice and supervision of a doctor

Warnings

Warnings • for external use only • avoid contact with eyes • do not put this productinto rectum by using fingers or any mechanical device or applicator Consult a doctor:• before use if you have a vaginal discharge (for external feminine itching) • forexternal itching, do not exceed the recommended daily dosage or if bleeding occurs •if condition When using this product: • avoid contact with eyes • do not put thisproduct into rectum by using fingers or any mechanical device or applicator worsensor if symptoms persist for more than 7 days or clear up and occur again within a fewdays • ask a doctor before use if you are using any other hydrocortisone product

Otc - Do Not Use

Do Not Use • with any other Hydrocortisone product unless you have consulted adoctor

Otc - Keep Out Of Reach Of Children

• KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help orcontact a Poison Control Center right away.

Dosage & Administration

Directions: • For adults and children 2 years of age and older: apply to affected areanot more than 3 to 4 times daily • Children under 2 years of age: do not use, consult adoctor • Adults for external anal itching when practical, cleanse the affected area withmild soap and warm water and rinse thoroughly or by patting or blotting with anappropriate cleansing pad • Gently dry by patting or blotting with toilet tissue or asoft cloth before application of this product • Children under 12 years of age: forexternal anal itching, consult a doctor

Other Safety Information

Other Information: • Store at controlledroom temperature 15° to 30° C(59° to 86° F) • Tamper evident. Do notuse if packet is torn, cut, or opened• Avoid excessive heat and humidity

Inactive Ingredient

Inactive Ingredients: Water, CetarylAlcohol, Glycerin, Ceteareth-20,Isopropyl Mistrate, EDTA-2NA,Phenoxyethanol, Tocopheryl Acetate,Aloe Barbadensis leaf Juice

Product Package

Aramark25 ct. of 1g packetsPart # 608R23MAXIMUM STRENGTHHYDROCORTISONEPLUS MOISTURIZING ALOEcompare toHydrocortisone1% ANTI-ITCH ANALGESIC • FOR THETEMPORARY RELIEFOF MINOR SKIN IRRITATIONSRetain carton for complete product informationMANUFACTURED BY:AramarkLenexa, KS 66219 (913) 269-9611aramarkuniform.com25 Count6 Count

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