NDC 71825-107 Beard Medicated Cremo

Hydrocortisone

NDC Product Code 71825-107

NDC Product Information

Beard Medicated Cremo with NDC 71825-107 is a a human over the counter drug product labeled by Cremo Company. The generic name of Beard Medicated Cremo is hydrocortisone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Cremo Company

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.


Beard Medicated Cremo 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 1 g/100g

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.

  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • TEA TREE OIL (UNII: VIF565UC2G)
  • PEPPERMINT (UNII: V95R5KMY2B)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • COCOA BUTTER (UNII: 512OYT1CRR)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • WATER (UNII: 059QF0KO0R)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
  • ALLANTOIN (UNII: 344S277G0Z)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

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: Cremo Company
Labeler Code: 71825
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: 01-17-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

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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]

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Beard Medicated Cremo Product Label Images

Beard Medicated Cremo 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

Otc - Active Ingredient

Active Ingredients PurposeHydrocortisone 1% Anti-itch

Otc - Purpose

UsesFor temporary relief of itching and minor skin irritation associated to eczema, soaps, detergents, and minor scrapes or scratches

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

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

Warnings

  • WarningsFor External use only When using this product avoid contact with eyes
  • If contact occurs, rinse eyes thoroughly with water

Dosage & Administration

DirectionsFor adults: apply to affected area not more than 3 to 4 times daily.

Inactive Ingredient

Inactive Ingredients Water, Ethylhexyl Palmitate, Cetyl Alcohol, Glycerin, Butylene Glycol, Glyceryl Stearate, Stearic Acid, Coconut Oil, Cocoa Butter, Caprylyl Glycol, Phenoxyethanol, Hexylene Glycol, Cetearyl Alcohol, Polysorbate 60, Carbomer, Aminomethyl Propanol, Disodium EDTA, Allantoin, Vitamin E Acetate, Aloe Vera Leaf Extract, Organic Tea Tree Leaf Oil, Lavender Oil, Peppermint Oil, Organic Chamomile Blue (German) Flower Oil.

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